ITL Dental
IHW4211 4.2 X 11.5mm Internal Hex Implants, WP with IM Mount, 3.5 Platform
7manufacturers in China registered for this device type
603catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Sichuan (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Basic (Chengdu) Medical Device Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 1 |
| Dongguan Xinlonghong Hardware Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| BIO Concept Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Emery Enterprises Inc., United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-13 |
| Record revised | 2022-12-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SLW-1110 Straight Abutment 4.5 platform, Smooth | In distribution | |
| TMU-0532 Titanium Sleeve Short | In distribution | |
| HCM-5040S | In distribution | |
| AMU-1831 | In distribution | |
| IHAW5285.2 X 8mm Internal Hex ImplantWP, HA | In distribution | |
| SBT-1015 | In distribution | |
| IHAW3710A | In distribution | |
| WCM-0030-SPE Retained Overdenture Abutment, Set | In distribution | |
| EMA-3051-W Angled Abutment , Two Pieces, 4.5 Platform | In distribution | |
| TMC-100003 Closed Tray Concave Long Transfer, 6mmL | In distribution | |
| IHW3713 3.7 X 13mm Internal Hex Implants, WP with IM Mount, 3.5 Platform | In distribution | |
| ITC-0010 Immediate Temporary Conical | In distribution | |
| IHW4216A 4.2 x 16mm WP Internal Hex Implant | In distribution | |
| IHW378A 3.7 x 8mm WP Internal Hex Implant | In distribution | |
| AMU-3001-W Angled Abutment , One Piece, 4.5 Platform | In distribution | |
| ACM-1315-40P Angled Abutment 3.5 Platform, Peek | In distribution | |
| EMA-0921-M Angled Abutment , Two Pieces, 3.5 Platform | In distribution | |
| IHAW3713 3.7 X 13mm Internal Hex Implant WP, HA | In distribution | |
| GAHM-09 9° Angled Gauge | In distribution | |
| IHAW4784.7 X 8mm Internal Hex ImplantWP, HA | In distribution | |
| IHAW328A | In distribution | |
| IH4210 4.2 X 10mm Internal Hex Implant | In distribution | |
| WCA-1830-W 18° Angular Overdenture Attachment, Set | In distribution | |
| WCA-0940-M 9° Angular Overdenture Attachment, Set | In distribution | |
| IHAW4716 4.7 X 16mm Internal Hex Implant WP, HA | In distribution | |
| PROCLSL | In distribution | |
| IHP5210 5.2 X 10mm NP Implant, 3.5 Platform | In distribution | |
| PDT | In distribution | |
| BWS-4020 Ball Attachment Screw, 4.5 Platform | In distribution | |
| IHW3716A 3.7 x 16mm WP Internal Hex Implant | In distribution | |
| TMU-1100 Open Tray Transfer | In distribution | |
| SWS-0040 Titanium Abutments for 3D, Non-Hex Base | In distribution | |
| EMA-1851-M Angled Abutment , Two Pieces, 3.5 Platform | In distribution | |
| BMA-0940-S MLS System 9 Degree Angled Ball Connection Set | In distribution | |
| SMS-0040 Titanium Abutments for 3D, Non-Hex Base | In distribution | |
| BMA-0930-S MLS System 9 Degree Angled Ball Connection Set | In distribution | |
| IHW4213A 4.2 x 13mm WP Internal Hex Implant | In distribution | |
| HCC-4550 MLS Healing Cap | In distribution | |
| IHAW378 3.7 X 8mm Internal Hex ImplantWP, HA | In distribution | |
| STP08 | In distribution | |
| WCA-3020-W 30° Angular Overdenture Attachment, Set | In distribution | |
| AMU-1821-M Angled Abutment , One Piece, 3.5 Platform | In distribution | |
| IH4711A 4.7 x 11mm NP Internal Hex Implant | In distribution | |
| BMA-0950-S MLS System 9 Degree Angled Ball Connection Set | In distribution | |
| A57S 5.7 mm | In distribution | |
| WCM-0030 Retained Overdenture Abutment | In distribution | |
| RSSC | In distribution | |
| HCM-3740S | In distribution | |
| IH3213 3.2 X 13mm Internal Hex Implant | In distribution | |
| SWS-6040 Titanium Abutments for 3D, Hex Base | In distribution | |
| IH4711 4.7 X 11.5mm Internal Hex Implant | In distribution | |
| IHWP5208 5.2 X 8mm WP Implant, 3.5 Platform | In distribution | |
| STM-0910 Straight Abutment 3.5 platform, with grooves | In distribution | |
| HCW-6040 Healing Cap 4.5p | In distribution | |
| ACCM-1325-3025º Aesthetic Abutment and Screw | In distribution | |
| HCM-5040 Healing Cap 3.5p | In distribution | |
| AMB-1201 | In distribution | |
| IH3211A 3.2 x 11mm NP Internal Hex Implant | In distribution | |
| IHW4216 4.2 X 16mm Internal Hex Implants, WP with IM Mount, 3.5 Platform | In distribution | |
| IHAW4710A | In distribution | |
| WCA-1850-M 18° Angular Overdenture Attachment, Set | In distribution | |
| IH328 3.2 X 8mm Internal Hex Implant | In distribution | |
| ECA-6025 Aesthetic Connection Abutment with Hex | In distribution | |
| TWC-1105 OLS Transfer | In distribution | |
| TSU-1250 Titanium Sleeve | In distribution | |
| IHAW3716 3.7 X 16mm Internal Hex Implant WP, HA | In distribution | |
| ACM-1215-30 Angled Abutment 3.5 Platform | In distribution | |
| IHW3713A 3.7 x 13mm WP Internal Hex Implant | In distribution | |
| IM57 | In distribution | |
| WCC-0030 Connection for EMU and EWU MLS Adaptors | In distribution | |
| EMU-0051 Straight Aesthetic Adaptor Abutment, 3.5P | In distribution | |
| IHP5211 5.2 X 11.5mm NP Implant, 3.5 Platform | In distribution | |
| WCP-2348-H Hard Housing | In distribution | |
| IHAW3716A | In distribution | |
| IH5713A 5.7 x 13mm NP Internal Hex Implant | In distribution | |
| BMA-0030 MLS System Ball Connection, Straight | In distribution | |
| BWT-0030-S Ball Attachment Screw, 4.5 Platform | In distribution | |
| IHAW5216 5.2 X 16mm Internal Hex Implant WP, HA | In distribution | |
| IH5711A 5.7 x 10mm NP Internal Hex Implant | In distribution | |
| BMA-1820-S | In distribution | |
| BWS-4060 Ball Attachment Screw, 4.5 Platform | In distribution | |
| TWC-0930 Titanium Transfer, 4.5 Platform | In distribution | |
| SCCM-1440 Straight Aesthetic Abutment and Screw | In distribution | |
| IHAW3216A | In distribution | |
| IHAWP5211A | In distribution | |
| AMU-3021-M Angled Abutment , One Piece, 3.5 Platform | In distribution | |
| SCSC-1720 Screw for Scanning Abutment | In distribution | |
| TMP-0010 Plastic Cap | In distribution | |
| WCC-0020 Connection for EMU and EWU MLS Adaptors | In distribution | |
| IHWP4716 4.7 X 16mm WP Implant, 3.5 Platform | In distribution | |
| EMA-0941-M Angled Abutment , Two Pieces, 3.5 Platform | In distribution | |
| HCM-5070 Healing Cap 3.5p | In distribution | |
| WCA-3040-W 30° Angular Overdenture Attachment, Set | In distribution | |
| IH5211 5.2 X 11.5mm Internal Hex Implant | In distribution | |
| WCA-9030-W 9° Angular Overdenture Attachment, Set | In distribution | |
| IHAW5213 5.2 X 13mm Internal Hex Implant WP, HA | In distribution | |
| CPA-1405 | In distribution | |
| IH4710A 4.7 x 10mm NP Internal Hex Implant | In distribution | |
| IHW4211 4.2 X 11.5mm Internal Hex Implants, WP with IM Mount, 3.5 Platform | In distribution | |
| HCW-6050S | In distribution | |
| WCA-1850-W 18° Angular Overdenture Attachment, Set | In distribution | |
| ACCM-1425-4025 Aesthetic Abutment and Screw | In distribution | |
| BMT-0010-S Ball Attachment Screw, 3.5 Platform | In distribution | |
| SCA-2565 Screw for Plastic Abutments | In distribution | |
| IH578A 5.7 x 8mm NP Internal Hex Implant | In distribution | |
| EMA-0951-W Angled Abutment , Two Pieces, 4.5 Platform | In distribution | |
| IHAW4713 4.7 X 13mm Internal Hex Implant WP, HA | In distribution | |
| IHAWP5213A | In distribution | |
| IHAW4210 4.2 X 10mm Internal Hex Implant WP, HA | In distribution | |
| ACW-1215-20 Angled Abutment 4.5 Platform | In distribution | |
| EMU-0021 Straight Aesthetic Adaptor Abutment, 3.5P | In distribution | |
| BMA-0040 MLS System Ball Connection, Straight | In distribution | |
| BWT-0040-S Ball Attachment Screw, 4.5 Platform | In distribution | |
| ACM-1215-30P Angled Abutment 3.5 Platform, Peek | In distribution | |
| ASM-1325 Angled Abutment 3.5 Platform | In distribution | |
| IM37 | In distribution | |
| MUC-0051 Multi Unit Connection | In distribution | |
| PES-1240 For ECA Hex Base | In distribution | |
| IHW528 5.2 X 8mm Internal Hex Implants, WP with IM Mount, 4.5 Platform | In distribution | |
| IH4716 4.7 X 16mm Internal Hex Implant | In distribution | |
| IHW528A 5.2 x 8mm WP Internal Hex Implant | In distribution | |
| ASM-0915 Angled Abutment 3.5 Platform | In distribution | |
| IH4713 4.7 X 13mm Internal Hex Implant | In distribution | |
| IHWP5210 5.2 X 10mm WP Implant, 3.5 Platform | In distribution | |
| EMA-1861-W Angled Abutment , Two Pieces, 4.5 Platform | In distribution | |
| BWT-0060-S Ball Attachment Screw, 4.5 Platform | In distribution | |
| BMA-0020 MLS System Ball Connection, Straight | In distribution | |
| BWT-0020-S Ball Attachment Screw, 4.5 Platform | In distribution | |
| CS45 | In distribution | |
| IHD5RAS | In distribution | |
| IHW428A 4.2 x 8mm WP Internal Hex Implant | In distribution | |
| HCW-6040S | In distribution | |
| EWU-0061 Straight Aesthetic Adaptor Abutment, 4.5P | In distribution | |
| IHAW3710 3.7 X 10mm Internal Hex Implant WP, HA | In distribution | |
| SSM-0008 Ultra Slim Straight Abutment, 3.5P | In distribution | |
| HCW-6030S | In distribution | |
| WCM-0020-SPE Retained Overdenture Abutment, Set | In distribution | |
| TMC-0930 Titanium Transfer, 3.5 Platform | In distribution | |
| IH478 4.7 X 8mm Internal Hex Implant | In distribution | |
| HCM-4060S | In distribution | |
| IHW478A 4.7 x 8mm WP Internal Hex Implant | In distribution | |
| IHAW4216 4.2 X 16mm Internal Hex Implant WP, HA | In distribution | |
| AMU-3021 | In distribution | |
| ACM-1115-10P | In distribution | |
| GAHM-18 18° Angled Gauge | In distribution | |
| IH5713 5.7 X 13mm Internal Hex Implant | In distribution | |
| SCCM-1220 Straight Aesthetic Abutment and Screw | In distribution | |
| PSW-0013 Plastic Abutment – Non-Hex Base | In distribution | |
| SCS-3011 Connection Screw | In distribution | |
| IHAW5210A | In distribution | |
| WCM-0040-SPE Retained Overdenture Abutment, Set | In distribution | |
| EMA-1831-M Angled Abutment , Two Pieces, 3.5 Platform | In distribution | |
| TWC-0940 Titanium Transfer, 4.5 Platform | In distribution | |
| STP10 | In distribution | |
| MUC-0021 Multi Unit Connection | In distribution | |
| WCA-3030-M 30° Angular Overdenture Attachment, Set | In distribution | |
| WCA-1820-M 18° Angular Overdenture Attachment, Set | In distribution | |
| WCA-0940-W 9° Angular Overdenture Attachment, Set | In distribution | |
| HCM-3740 Healing Cap 3.5p, Ultra Slim | In distribution | |
| WCA-0930-M 9° Angular Overdenture Attachment, Set | In distribution | |
| SCW-1330 Straight Abutment 4.5 platform | In distribution | |
| HCM-3750S | In distribution | |
| BHM-5032 Stainless Steel Ball Housing | In distribution | |
| IHW328A 3.2 x 8mm WP Internal Hex Implant | In distribution | |
| IHW3711A 3.7 x 11mm WP Internal Hex Implant | In distribution | |
| BMA-0920-S MLS System 9 Degree Angled Ball Connection Set | In distribution | |
| SCCW-1220 Straight Aesthetic Abutment and Screw | In distribution | |
| IHW4210 4.2 X 10mm Internal Hex Implants, WP with IM Mount, 3.5 Platform | In distribution | |
| ACM-1325-30 Angled Abutment 3.5 Platform | In distribution | |
| ASM-1125 Angled Abutment 3.5 Platform | In distribution | |
| IHWP521 5.2 X 16mm WP Implant, 3.5 Platform | In distribution | |
| TMU-1000 | In distribution | |
| WCA-1840-W 18° Angular Overdenture Attachment, Set | In distribution | |
| ECA-6005 Aesthetic Connection Abutment with Hex | In distribution | |
| WCA-0950-M 9° Angular Overdenture Attachment, Set | In distribution | |
| TWC-0910 Titanium Transfer, 4.5 Platform | In distribution | |
| IH5711 5.7 X 11.5mm Internal Hex Implant | In distribution | |
| BMS-4060 Ball Attachment Screw, 3.5 Platform | In distribution | |
| IH428A 4.2 x 8mm NP Internal Hex Implant | In distribution | |
| BMS-4050 Ball Attachment Screw, 3.5 Platform | In distribution | |
| IH4213A 4.2 x 13mm NP Internal Hex Implant | In distribution | |
| HCM-4040S | In distribution | |
| IHW5210A 5.2 x 10mm WP Internal Hex Implant | In distribution | |
| SSM-0006 Ultra Slim Straight Abutment, 3.5P | In distribution | |
| GAHM-SET Set of 4 Gauges: 00, 09, 18, & 30 | In distribution | |
| IH4213 4.2 X 13mm Internal Hex Implant | In distribution | |
| SCT-3023 Connection Screw | In distribution | |
| IH3210 3.2 X 10mm Internal Hex Implant | In distribution | |
| TPA-1420R Titanium Plastic Abutment Non-Hex Base | In distribution | |
| IHD5RAL | In distribution | |
| ACM-1215-20P Angled Abutment 3.5 Platform, Peek | In distribution | |
| ACCM-1415-4015ºAesthetic Abutment and Screw | In distribution | |
| IHW3211 3.2 X 11.5mm Internal Hex Implants, WP with IM Mount, 3.5 Platform | In distribution | |
| WCM-0000 Retained Overdenture Abutment | In distribution | |
| ACCM-1215-20 15º Aesthetic Abutment and Screw | In distribution | |
| IH5216A 5.2 x 16mm NP Internal Hex Implant | In distribution | |
| SLW-1330 Straight Abutment 4.5 platform, Smooth | In distribution | |
| IHP5216 5.2 X 16mm NP Implant, 3.5 Platform | In distribution | |
| IHAW3210 3.2 X 10mm Internal Hex Implant WP, HA | In distribution | |
| IHWP4713 4.7 X 13mm WP Implant, 3.5 Platform | In distribution | |
| AMU-1201 Analog, MLS System | In distribution | |
| RSC | In distribution | |
| BMT-0020-S Ball Attachment Screw, 3.5 Platform | In distribution | |
| AMU-1201 Analog for MLS | In distribution | |
| SCIE-2510 Screw for Internal External Abutment | In distribution | |
| ACM-1115-10 Angled Abutment 3.5 Platform | In distribution | |
| IHWP4710 4.7 X 10mm WP Implant, 3.5 Platform 3.5 Platform | In distribution | |
| IHDRAL | In distribution | |
| IHW5211 5.2 X 11.5mm Internal Hex Implants, WP with IM Mount, 4.5 Platform | In distribution | |
| SCP-2580 Screw for Plastic Abutments | In distribution | |
| EMU-0011 Straight Aesthetic Adaptor Abutment, 3.5P | In distribution | |
| SLM-1330P Straight Abutment 3.5 platform, Peek | In distribution | |
| EWU-1810 18 Degree Adaptor | In distribution | |
| TSM-1013 | In distribution | |
| HCW-6060 Healing Cap 4.5p | In distribution | |
| IHW3710 3.7 X 10mm Internal Hex Implants, WP with IM Mount, 3.5 Platform | In distribution | |
| HCW-6080S | In distribution | |
| SLM-1226 Straight Abutment 3.5 platform, with hex retention | In distribution | |
| IHAWP4711A | In distribution | |
| EWU-0031 Straight Aesthetic Adaptor Abutment, 4.5P | In distribution | |
| CPA-1405-R | In distribution | |
| STM-1310 Straight Abutment 3.5 platform, with grooves | In distribution | |
| WCP-2348 Direct Peek Attachment | In distribution | |
| IHAW3213A | In distribution | |
| IH578 5.7 X 8mm Internal Hex Implant | In distribution | |
| BIS-0025 Silicone Ball Insert | In distribution | |
| IHAWP4713A | In distribution | |
| BMT-0040-S Ball Attachment Screw, 3.5 Platform | In distribution | |
| ACM-1215-20 Angled Abutment 3.5 Platform | In distribution | |
| CPA-1430-R Plastic Abutment, Round Base, 3mmH, 3.5P | In distribution | |
| RSC62 | In distribution | |
| IHWP5211 5.2 X 11.5mm WP Implant, 3.5 Platform | In distribution | |
| ACM-1315-40 Angled Abutment 3.5 Platform | In distribution | |
| SCS-3095 Screw for Abutment Connection | In distribution | |
| RSC35 | In distribution | |
| IHAW5216A | In distribution | |
| BMT-0050-S Ball Attachment Screw, 3.5 Platform | In distribution | |
| WCH-5628 Housing Cover | In distribution | |
| PSU-0050 | In distribution | |
| IHW4713 4.7 X 13mm Internal Hex Implants, WP with IM Mount, 4.5 Platform | In distribution | |
| IH378 3.7 X 8mm Internal Hex Implant | In distribution | |
| CCP-00 Peek Cover, Non-Engaging | In distribution | |
| HCW-6070S | In distribution | |
| PES-1240R For ECA Non-Hex Base | In distribution | |
| EMA-3031-M Angled Abutment , Two Pieces, 3.5 Platform | In distribution | |
| HCM-5050 Healing Cap 3.5p | In distribution | |
| EMU-0031 Straight Aesthetic Adaptor Abutment, 3.5P | In distribution | |
| IHWP4711 4.7 X 11.5mm WP Implant, 3.5 Platform | In distribution | |
| EMA-3041-M Angled Abutment , Two Pieces, 3.5 Platform | In distribution | |
| AMU-3031 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 920 |
| Osstem Implant System | Osstem Implant Co., Ltd. | 788 |
| Magicore | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 744 |
| Implant, Endosseous, Root-Form | Southern Implants (PTY) Ltd | 608 |
| Magicore S | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 560 |
| Friadent® | Dentsply Implants Manufacturing GmbH | 525 |
| Sphero Block Normo | Rhein 83 SRL | 489 |
| Neobiotech Implant System | Neobiotech Co., Ltd. | 483 |
| KJ Mini Implant System | Kjmeditech.co., Ltd. | 448 |
| Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | 418 |
| Leone SPA | Leone SPA | 404 |
| Ankylos® | Dentsply Implants Manufacturing GmbH | 391 |
Showing 12 of 2,762. All products under Implant, Endosseous, Root-Form
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P800035 | 2001-10-04 | PERI-OSS | Curasan AG |
| P860012 | 1988-10-28 | ALVEOFORM TM BIOGRAFT | Collagen Corp. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.