SM Internal/External Implant Systems
390 catalogue numbers from IPI 48004, listed by DIO Corporation, South Korea, under Implant, Endosseous, Root-Form. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
390catalogue numbers in this listing
7510(k) clearances naming this product code
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 | DIO Corporation, South Korea |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K070569 |
| Record published | 2016-01-18 |
| Record revised | 2022-02-28 (version 5) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 1 to 30 °C |
| Distribution end date | 2022-02-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPI 48004 | Ø5.2X10.2mm | In distribution |
| TMT 50612 | Ø5.5X12.0mm | In distribution |
| TCN 40511 | Ø5.4X11.0mm | In distribution |
| TMN 40512 | Ø4.5X12.0mm | In distribution |
| RMI 48004EX | Ø4.8X4.0mm | In distribution |
| TCN 40512 | Ø5.4X12.0mm | In distribution |
| TMN 35412N | Ø4.0X12.0mm | In distribution |
| HMI 65705 | Ø7.5X5.5mm | In distribution |
| AAT 50225 | Ø6.0X2.0mm | In distribution |
| RMI 48007EX | Ø4.8X7.0mm | In distribution |
| AGT 50614 | Ø5.5X4.1mm | In distribution |
| AAI 35015 | Ø3.5X15.0(Cuff)mm | In distribution |
| IPI 48610 | Ø5.5X10.0mm | In distribution |
| TMN 35412 | Ø4.0X12.0mm | In distribution |
| TMN 50612N | Ø5.5X12.0mm | In distribution |
| TMN 50612 | Ø5.5X12.0mm | In distribution |
| IPI 48610N | Ø5.5X10.0mm | In distribution |
| TCN 40511N | Ø5.4X11.0mm | In distribution |
| TCN 40512N | Ø5.4X12.0mm | In distribution |
| AHI 48604H | Ø5.5X4.0mm | In distribution |
| RMI 48005EX | Ø4.8X5.5mm | In distribution |
| TMN 40512N | Ø4.5X12.0mm | In distribution |
| TMT 50612N | Ø5.5X12.0mm | In distribution |
| PCN 40308 | Ø1.4X8.0mm | Withdrawn |
| PCN 40310 | Ø1.4X10.0mm | Withdrawn |
| AMN 40539 | Ø5.0X9.0mm | Withdrawn |
| AHN 50608 | Ø6.0X8.0mm | Withdrawn |
| PMN 35310 | Ø1.6X10.0mm | Withdrawn |
| PCN 40312 | Ø1.4X12.0mm | Withdrawn |
| IPI 65002Y | 10.0mm(Yellow) | Withdrawn |
| IPN 40508 | Ø4.8X8.0mm | Withdrawn |
| IPI 65710N | Ø7.0X10.35mm | Withdrawn |
| AMN 40540N | Ø6.0X10.0mm | Withdrawn |
| IPT 50612 | Ø5.8X12.0mm | Withdrawn |
| APN 50613N | Ø5.5X13.0mm | Withdrawn |
| IPN 40508N | Ø4.8X8.0mm | Withdrawn |
| POI 2610 | Ø2.5X10.0mm | Withdrawn |
| ABI 48352 | Ø3.5X2.0mm | Withdrawn |
| CHN 4000N | Ø1.6X4.2mm | Withdrawn |
| RMT 50512 | Ø5.0X12.0mm | Withdrawn |
| APN 40513 | Ø4.5X13.0mm | Withdrawn |
| IPI 65004N | Ø6.9X7.13mm | Withdrawn |
| ITI 48010 | Ø4.8X9.5mm | Withdrawn |
| AMI 48435EX | Ø4.3X5.5mm | Withdrawn |
| RCN 40412 | Ø4.8X11.9mm | Withdrawn |
| HMI 65704 | Ø7.5X4.0mm | Withdrawn |
| AAT 50415 | Ø6.0X4.0mm | Withdrawn |
| SHN 2011S | Ø3.1X4.0mm | Withdrawn |
| AMT 50639N | Ø6.0X9.0mm | Withdrawn |
| AHN 40605 | Ø6.0X5.0mm | Withdrawn |
| IPI 65004 | Ø6.9X7.13mm | Withdrawn |
| AGN 40514 | Ø4.5X4.1mm | Withdrawn |
| AEI 48037N | Ø5.0X3.0(Cuff)mm | Withdrawn |
| AAT 50425 | Ø6.0X4.0mm | Withdrawn |
| AMT 50628 | Ø6.0X8.0mm | Withdrawn |
| AMN 35442N | Ø4.0X12.0mm | Withdrawn |
| TMT 50612N | Ø5.5X12.0mm | Withdrawn |
| ACN 40512 | Ø4.8X1.0(Cuff)mm | Withdrawn |
| AMT 50642 | Ø6.0X12.0mm | Withdrawn |
| AMT 50620N | Ø6.0X10.0mm | Withdrawn |
| CHT 5001 | Ø5.0X5.8mm | Withdrawn |
| AHN 40505 | Ø5.0X5.0mm | Withdrawn |
| ACT 50612 | Ø5.5X1.0(Cuff)mm | Withdrawn |
| AHN 40503 | Ø5.0X3.0mm | Withdrawn |
| APN 40514N | Ø5.2X14.0mm | Withdrawn |
| IPN 40510 | Ø4.8X9.4mm | Withdrawn |
| TMN 50612N | Ø5.5X12.0mm | Withdrawn |
| IPN 4008 | Ø4.8X8.0mm | Withdrawn |
| TMN 35412N | Ø4.0X12.0mm | Withdrawn |
| SHN 2009S | Ø3.1X2.0mm | Withdrawn |
| RCI 65014 | Ø6.5X14.2mm | Withdrawn |
| APT 50613N | Ø5.5X13.0mm | Withdrawn |
| AHT 50604 | Ø6.0X4.0mm | Withdrawn |
| AMI 48434EX | Ø4.3X4.0mm | Withdrawn |
| APN 40513N | Ø4.5X13.0mm | Withdrawn |
| ACN 40534 | Ø4.8X3.0(Cuff)mm | Withdrawn |
| AEI 48017 | Ø5.0X1.0(Cuff)mm | Withdrawn |
| AMT 50640 | Ø6.0X10.0mm | Withdrawn |
| IPN 50608N | Ø5.5X8.0mm | Withdrawn |
| AMN 50642 | Ø6.0X12.0mm | Withdrawn |
| AMN 40531N | Ø5.0X11mm | Withdrawn |
| RBN 40412 | Ø4.1X12.0mm | Withdrawn |
| AHN 50604 | Ø6.0X4.0mm | Withdrawn |
| AMT 50642N | Ø6.0X12.0mm | Withdrawn |
| AGN 50614 | Ø5.5X4.1mm | Withdrawn |
| AHN 50602 | Ø6.0X2.0mm | Withdrawn |
| AMN 40517 | Ø5.0X7.0mm | Withdrawn |
| AMN 40542N | Ø5.0X12.0mm | Withdrawn |
| AHN 35405 | Ø4.0X5.0mm | Withdrawn |
| TMN 40512N | Ø4.5X12.0mm | Withdrawn |
| AHN 35406 | Ø4.0X6.0mm | Withdrawn |
| AHN 40602 | Ø6.0X2.0mm | Withdrawn |
| AGI 48504N | Ø5.0X4.0mm | Withdrawn |
| PMN 35315 | Ø1.6X15.0mm | Withdrawn |
| IPI 48002GEX | 5.7mm(Gray) | Withdrawn |
| RMI 48012 | Ø4.8X12.0mm | Withdrawn |
| ITN 50612H | Ø6.0X9.5mm | Withdrawn |
| AHI 65703H | Ø7.0X3.0mm | Withdrawn |
| AMT 50619 | Ø6.0X9.0mm | Withdrawn |
| IPI 48012 | Ø5.5X12.4mm | Withdrawn |
| TCN 40512N | Ø5.4X12.0mm | Withdrawn |
| TCN 40512 | Ø5.4X12.0mm | Withdrawn |
| IPI 48008 | Ø5.5X8.4mm | Withdrawn |
| AGT 50614N | Ø5.5X4.1mm | Withdrawn |
| AGN 50614N | Ø5.5X4.1mm | Withdrawn |
| IPN 3508 | Ø3.8X8.0mm | Withdrawn |
| SHN 2509 | Ø3.6X2.0mm | Withdrawn |
| AMI 48017 | Ø4.8X1.0(Cuff)mm | Withdrawn |
| API 65714N | Ø7.0X10.0mm | Withdrawn |
| AMN 40542 | Ø5.0X12.0mm | Withdrawn |
| CHN 5000N | Ø2.5X4.2mm | Withdrawn |
| AAI 35015B | Ø3.5X15.0(Cuff)mm | Withdrawn |
| AMN 35431N | Ø4.0X11.0mm | Withdrawn |
| AMN 35442 | Ø4.0X10.0mm | Withdrawn |
| AMN 40539N | Ø5.0X9.0mm | Withdrawn |
| AEI 48027N | Ø5.0X2.0(Cuff)mm | Withdrawn |
| AMN 40619N | Ø6.0X9.0mm | Withdrawn |
| AHN 50605 | Ø6.0X5.0mm | Withdrawn |
| AMN 40617 | Ø6.0X7.0mm | Withdrawn |
| ITT 50612 | Ø6.0X11.0mm | Withdrawn |
| RMI 48004N | Ø4.8X4.0mm | Withdrawn |
| AMN 50620N | Ø6.0X10.0mm | Withdrawn |
| SHN 2012 | Ø2.95X4.0mm | Withdrawn |
| IPN 50612N | Ø5.8X12.0mm | Withdrawn |
| RT 0502 | Ø5.0X2.0mm | Withdrawn |
| AMT 50631 | Ø6.0X11.0mm | Withdrawn |
| SHN 2003 | Ø2.0X3.7mm | Withdrawn |
| AGN 40506 | Ø4.8X5.7mm | Withdrawn |
| APN 40514 | Ø5.2X14.0mm | Withdrawn |
| ITN 50612 | Ø6.0X11.0mm | Withdrawn |
| AMN 40619 | Ø6.0X9.0mm | Withdrawn |
| AMT 50640N | Ø6.0X10.0mm | Withdrawn |
| IPN 40510N | Ø4.8X8.0mm | Withdrawn |
| AHT 50602 | Ø6.0X2.0mm | Withdrawn |
| IPT 5008N | Ø5.8X8.0mm | Withdrawn |
| SHN 2010S | Ø3.1X3.0mm | Withdrawn |
| IPI 48002YEX | 5.7mm(Yellow) | Withdrawn |
| AMN 35439N | Ø4.0X9.0mm | Withdrawn |
| AMN 40640 | Ø6.0X10.0mm | Withdrawn |
| AHN 40608 | Ø6.0X8.0mm | Withdrawn |
| AMT 50639 | Ø6.0X9.0mm | Withdrawn |
| APN 40514SN | Ø5.2X13.0mm | Withdrawn |
| AMI 65435 | Ø4.3X5.5mm | Withdrawn |
| APN 35413 | Ø4.0X13.0mm | Withdrawn |
| ITN 40512 | Ø5.0X11.0mm | Withdrawn |
| HMI 48555EX | Ø5.5X5.5mm | Withdrawn |
| IPN 3508N | Ø3.8X8.0mm | Withdrawn |
| HMI 48554EX | Ø5.5X4.0mm | Withdrawn |
| AAN 40415 | Ø5.0X4.0mm | Withdrawn |
| TMN 40512 | Ø4.5X12.0mm | Withdrawn |
| AMN 40520 | Ø5.0X10.0mm | Withdrawn |
| ACT 50634 | Ø5.5X3.0(Cuff)mm | Withdrawn |
| AMN 35431 | Ø4.0X11.0mm | Withdrawn |
| AGN 40504 | Ø4.8X3.55mm | Withdrawn |
| CHI 4800NH | Ø3.5X5.5mm | Withdrawn |
| AMN 50617N | Ø6.0X7.0mm | Withdrawn |
| AGN 35414 | Ø4.0X4.1mm | Withdrawn |
| TCN 50611 | Ø6.0X11.0mm | Withdrawn |
| ACN 40513 | Ø4.8X1.0(Cuff)mm | Withdrawn |
| AMN 40642N | Ø6.0X12.0mm | Withdrawn |
| TCN 40511 | Ø5.4X11.0mm | Withdrawn |
| AMI 48037 | Ø4.8X3.0(Cuff)mm | Withdrawn |
| ABN 40503 | Ø4.5X3.0mm | Withdrawn |
| AEI 48007N | Ø5.0X0.0(Cuff)mm | Withdrawn |
| AMN 40519N | Ø5.0X9.0mm | Withdrawn |
| ITN 40512S | Ø4.0X16mm | Withdrawn |
| RMI 48004EX | Ø4.8X4.0mm | Withdrawn |
| HMI 48557 | Ø5.5X7.0mm | Withdrawn |
| AMN 35420 | Ø4.0X10.0mm | Withdrawn |
| AHT 50603 | Ø6.0X3.0mm | Withdrawn |
| BC 5004 | Ø5.0X4.0mm | Withdrawn |
| RMI 48001 | Ø4.8X10.0mm | Withdrawn |
| AAN 35215 | Ø4.0X2.0mm | Withdrawn |
| API 48514 | Ø5.1X10.0mm | Withdrawn |
| AHT 50605 | Ø6.0X5.0mm | Withdrawn |
| AMN 35420N | Ø4.0X10.0mm | Withdrawn |
| RMI 65005N | Ø6.5X5.5mm | Withdrawn |
| AMN 40531 | Ø5.0X11.0mm | Withdrawn |
| AHI 65701H | Ø7.0X1.5mm | Withdrawn |
| AMN 50628N | Ø6.0X8.0mm | Withdrawn |
| AMT 50617N | Ø6.0X7.0mm | Withdrawn |
| AMN 35428N | Ø4.0X8.0mm | Withdrawn |
| HCN 50604 | Ø5.8X4.5mm | Withdrawn |
| IPI 65710 | Ø7.0X10.35mm | Withdrawn |
| SHT 2011S | Ø3.6X4.0mm | Withdrawn |
| ACN 40535 | Ø4.8X3.0(Cuff)mm | Withdrawn |
| ITT 50612H | Ø6.0.X9.5mm | Withdrawn |
| ACN 40545 | Ø4.8X4.0(Cuff)mm | Withdrawn |
| AAI 35025B | Ø3.5X25.0(Cuff)mm | Withdrawn |
| IPI 48004NEX | Ø5.2X10.2mm | Withdrawn |
| AAN 40225 | Ø5.0X2.0mm | Withdrawn |
| API 48514N | Ø5.1X10.0mm | Withdrawn |
| AMN 40517N | Ø5.0X7.0mm | Withdrawn |
| ITN 35412S | Ø3.2X16mm | Withdrawn |
| SSN 2003 | Ø2.0X3.0mm | Withdrawn |
| APT 50613 | Ø5.5X13.0mm | Withdrawn |
| AMN 40628N | Ø5.0X8.0mm | Withdrawn |
| SHN 2511 | Ø3.6X4.0mm | Withdrawn |
| CHN 3501 | Ø3.5X5.8mm | Withdrawn |
| SHN 2508 | Ø3.6X1.0mm | Withdrawn |
| AMI 48437EX | Ø4.3X7.0mm | Withdrawn |
| AHN 35403 | Ø4.0X3.0mm | Withdrawn |
| AMN 35439 | Ø4.0X9.0mm | Withdrawn |
| AEI 48007 | Ø5.0X0.0(Cuff)mm | Withdrawn |
| AMN 40620N | Ø6.0X10.0mm | Withdrawn |
| AMN 40639N | Ø5.0X10.0mm | Withdrawn |
| AMT 50619N | Ø6.0X9.0mm | Withdrawn |
| AHN 40603 | Ø6.0X3.0mm | Withdrawn |
| SSN 1404 | Ø1.4X3.6mm | Withdrawn |
| AEI 48017N | Ø5.0X1.0(Cuff)mm | Withdrawn |
| IPI 48004 | Ø5.2X10.2mm | Withdrawn |
| TMN 35412 | Ø4.0X12.0mm | Withdrawn |
| AHN 40508 | Ø5.0X8.0mm | Withdrawn |
| TCN 40511N | Ø5.4X11.0mm | Withdrawn |
| AMN 50628 | Ø6.0X8.0mm | Withdrawn |
| RCI 48014 | Ø4.8X14.0mm | Withdrawn |
| APN 50614N | Ø6.0X13.0mm | Withdrawn |
| RMI 48007N | Ø4.8X7.0mm | Withdrawn |
| AMN 50631 | Ø6.0X11.0mm | Withdrawn |
| SHT 2010S | Ø3.6X3.0mm | Withdrawn |
| IPI 48004EX | Ø5.2X10.2mm | Withdrawn |
| AMN 50639N | Ø6.0X9.0mm | Withdrawn |
| AEI 48037 | Ø5.0X3.0(Cuff)mm | Withdrawn |
| AHN 40506 | Ø5.0X6.0mm | Withdrawn |
| SHN 2009 | Ø2.95X1.0mm | Withdrawn |
| IPT 5008 | Ø5.8X8.0mm | Withdrawn |
| AHI 48604H | Ø5.5X4.0mm | Withdrawn |
| RMI 48007EX | Ø4.8X7.0mm | Withdrawn |
| AHN 40502 | Ø5.0X2.0mm | Withdrawn |
| IPN 5008N | Ø5.8X8.0mm | Withdrawn |
| AMI 48355 | Ø3.5X5.5mm | Withdrawn |
| AMN 50617 | Ø6.0X7.0mm | Withdrawn |
| AMT 50617 | Ø6.0X7.0mm | Withdrawn |
| CHN 4001 | Ø4.3X5.8mm | Withdrawn |
| HMI 48555 | Ø5.5X5.5mm | Withdrawn |
| AAN 50415 | Ø6.0X4.0mm | Withdrawn |
| SHT 2008S | Ø3.6X1.0mm | Withdrawn |
| AHI 48602H | Ø5.5X2.0mm | Withdrawn |
| RMN 50512 | Ø5.1X12.0mm | Withdrawn |
| AMN 40617N | Ø6.0X7.0mm | Withdrawn |
| RMI 48005N | Ø4.8X5.5mm | Withdrawn |
| PCN 50310 | Ø2.0X10.0mm | Withdrawn |
| AAI 35015 | Ø3.5X15.0(Cuff)mm | Withdrawn |
| ITT 50612S | Ø4.9X16mm | Withdrawn |
| AAN 40215 | Ø5.0X2.0mm | Withdrawn |
| AMN 35419 | Ø4.0X9.0mm | Withdrawn |
| ACT 50623 | Ø5.5X2.0(Cuff)mm | Withdrawn |
| AAN 40425 | Ø5.0X4.0mm | Withdrawn |
| AMI 48007 | Ø4.3X0.0(Cuff)mm | Withdrawn |
| ABN 40502 | Ø4.5X2.0mm | Withdrawn |
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 |
| ITL Dental | Emery Enterprises Inc. | 603 |
| 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 |
Showing 12 of 2,762. All products under Implant, Endosseous, Root-Form
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182194 | 2018-12-14 |
| K173975 | 2018-06-01 |
| K170608 | 2018-03-30 |
| K161987 | 2017-02-21 |
| K122519 | 2013-05-21 |
| K112746 | 2011-10-21 |
| K100100 | 2010-11-10 |
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.