Implant, Endosseous, Root-Form
Internal Octagon Max Tissue Level Implant, Ø6.5 Platform, Ø7.0 x 11mm
7manufacturers in China registered for this device type
608catalogue numbers in this listing
17510(k) clearances naming this product code
1recall
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 | Southern Implants (PTY) Ltd, South Africa |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K181850 |
| Record published | 2024-05-30 |
| Record revised | 2022-09-01 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| 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 |
| Distribution end date | 2024-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IVM-DC30-3710 | In distribution | |
| MSC-PRO12D508 | In distribution | |
| IVM-DC35-4515 | In distribution | |
| MSC-MAX-7-11 | In distribution | |
| IVM-DC50-6018 | In distribution | |
| ITC310 | In distribution | |
| ITT510F | In distribution | |
| TS-Z-MC-16 | In distribution | |
| BBBS10 | In distribution | |
| ZYGAN-55 | In distribution | |
| DCC5009 | In distribution | |
| MSC-IP-8.5 | In distribution | |
| IV-DC30-3713 | In distribution | |
| MSC-IBT-15 | In distribution | |
| BATI11.5 | In distribution | |
| MAX-9-7 | In distribution | |
| ITC412F | In distribution | |
| ZYGON-47.5 | In distribution | |
| BBBTI11.5 | In distribution | |
| DR-SP4516 | In distribution | |
| ZYGIN-W-52.5 | In distribution | |
| TS-Z-16 | In distribution | |
| DCC4013 | In distribution | |
| ZYGIN-47.5 | In distribution | |
| IBI7 | In distribution | |
| ZYGEX-47.5 | In distribution | |
| MSC-PROMAX811 | In distribution | |
| ZYGIN-W-40 | In distribution | |
| MSC-PROMAX707 | In distribution | |
| DCR5009 | In distribution | |
| IM-T5010 | In distribution | |
| ZYGON-37.5 | In distribution | |
| MSC-PRO311NF | In distribution | |
| ITT6-512F | In distribution | |
| MSC-IBNT-11.5 | In distribution | |
| CH-ZT-35.0 | In distribution | |
| ZYGAN-42.5 | In distribution | |
| MSC-PRO12D418 | In distribution | |
| DCT4009 | In distribution | |
| IBPS-13 | In distribution | |
| MSC-IBT-6 | In distribution | |
| ZYGEX-30 | In distribution | |
| BBBS7 | In distribution | |
| MAX-6-7 | In distribution | |
| MSC-BA6 | In distribution | |
| IM-T4208-12d | In distribution | |
| ITT510 | In distribution | |
| IM-T4210-12d | In distribution | |
| DCC3013 | In distribution | |
| MSC-SP4024 | In distribution | |
| MSC-SP5018 | In distribution | |
| MSC-BAT-15 | In distribution | |
| DR-SP4511 | In distribution | |
| IM-T4218 | In distribution | |
| MSC-PROMAX909 | In distribution | |
| MSC-BA8.5 | In distribution | |
| IV-EX30-3715 | In distribution | |
| ZYGIN-30 | In distribution | |
| PT-SP4024 | In distribution | |
| ZYGON-55 | In distribution | |
| IM-T5013 | In distribution | |
| BATI13 | In distribution | |
| MSC-PRO410 | In distribution | |
| I4B8.5 | In distribution | |
| ITC312F | In distribution | |
| MSC-PRO318 | In distribution | |
| DCT3515 | In distribution | |
| MSC-PRO12D308 | In distribution | |
| ZYGIN-W-60 | In distribution | |
| IVM-DC3512D-4511 | In distribution | |
| DR-SP4510 | In distribution | |
| MSC-SP4510 | In distribution | |
| ITC6-510F | In distribution | |
| ZYGIN-W-42.5 | In distribution | |
| ONC-55-27.5N | In distribution | |
| MSC-BAT-6 | In distribution | |
| BATI18 | In distribution | |
| ITT414 | In distribution | |
| MAX-9-11 | In distribution | |
| ZYGIN-45 | In distribution | |
| IBS13 | In distribution | |
| ITC306 | In distribution | |
| MSC-SP4516 | In distribution | |
| IM-T4215-12d | In distribution | |
| IM-T4208 | In distribution | |
| IP-13 | In distribution | |
| PRO308 | In distribution | |
| DR-SP3710 | In distribution | |
| BBBT6 | In distribution | |
| ITT608F | In distribution | |
| IVM-EX35-4518 | In distribution | |
| MSC-SP4011 | In distribution | |
| IBNT10 | In distribution | |
| PT-DC4020 | In distribution | |
| IVM-EX35-4513 | In distribution | |
| IV-EX30-3713 | In distribution | |
| ITT408F | In distribution | |
| MSC-PRO311 | In distribution | |
| MSC-IBT-8.5 | In distribution | |
| ZYG-55-60N | In distribution | |
| IVM-DC50-6010 | In distribution | |
| IM-T4213 | In distribution | |
| ITC510F | In distribution | |
| ITT410 | In distribution | |
| ITC308 | In distribution | |
| IBT18 | In distribution | |
| ZYGIN-50 | In distribution | |
| ZYG-55-42.5N | In distribution | |
| MSC-PRO315 | In distribution | |
| ONC-55-42.5N | In distribution | |
| ITC312 | In distribution | |
| ITC310F | In distribution | |
| MAX-6-9 | In distribution | |
| ITT6-508F | In distribution | |
| MSC-SP4008 | In distribution | |
| PRO12D308 | In distribution | |
| DCC3513 | In distribution | |
| ITC6-508 | In distribution | |
| ITC414F | In distribution | |
| IBTI15 | In distribution | |
| ZYGAN-35 | In distribution | |
| ZYGIN-W-30 | In distribution | |
| BBBT13 | In distribution | |
| PA-M-16T | In distribution | |
| MAX-9-9 | In distribution | |
| IV-DC30-3710 | In distribution | |
| BBBT18 | In distribution | |
| IVM-EX5212D-6015 | In distribution | |
| MSC-IBT-10 | In distribution | |
| IBNT15 | In distribution | |
| MSC-IBNT-8.5 | In distribution | |
| BAR36D-8.5 | In distribution | |
| MSC-SP6011 | In distribution | |
| IM-T3711 | In distribution | |
| DR-SP3708 | In distribution | |
| ZYGON-52.5 | In distribution | |
| MSC-SP3710 | In distribution | |
| MAX-8-11 | In distribution | |
| ITC410F | In distribution | |
| MSC-SP4010 | In distribution | |
| IVM-DC30-3711 | In distribution | |
| IBI15 | In distribution | |
| IVM-EX4012D-5018 | In distribution | |
| IBI13 | In distribution | |
| BAR36D-11.5 | In distribution | |
| IP-11.5 | In distribution | |
| IVM-EX3512D-4518 | In distribution | |
| BBBS11.5 | In distribution | |
| BAR36D-13 | In distribution | |
| MAXIT8-11F | In distribution | |
| IBS11.5 | In distribution | |
| IVM-DC40-5011 | In distribution | |
| IVM-DC4012D-5015 | In distribution | |
| MSC-PRO310NF | In distribution | |
| MSC-IBS15 | In distribution | |
| IVM-DC35-4508 | In distribution | |
| IV-DC30-3711 | In distribution | |
| ZYGIN-W-47.5 | In distribution | |
| ZYGON-45 | In distribution | |
| DCC3011 | In distribution | |
| MSC-PRO418 | In distribution | |
| ITC406 | In distribution | |
| IM-T4211 | In distribution | |
| ITC508F | In distribution | |
| IVM-DC50-6011 | In distribution | |
| MSC-PRO12D513 | In distribution | |
| ONC-55-37.5N | In distribution | |
| IBT15 | In distribution | |
| ZYGIN-W-55 | In distribution | |
| IBN15 | In distribution | |
| BAI8.5 | In distribution | |
| IBI10 | In distribution | |
| ITC314 | In distribution | |
| IVM-DC35-4513 | In distribution | |
| ZYGIN-40 | In distribution | |
| ZYGIN-32.5 | In distribution | |
| BATI15 | In distribution | |
| MSC-SP4022 | In distribution | |
| DCC4006 | In distribution | |
| MSC-PRO308 | In distribution | |
| BAI15 | In distribution | |
| ZYGEX-52.5 | In distribution | |
| IVM-DC4012D-5011 | In distribution | |
| PT-DC4022 | In distribution | |
| MSC-IBS10 | In distribution | |
| DCT4011 | In distribution | |
| MSC-PROMAX609 | In distribution | |
| MSC-SP3511 | In distribution | |
| BBBI15 | In distribution | |
| IBT6 | In distribution | |
| MAX-8-9 | In distribution | |
| MSC-SP4013 | In distribution | |
| MSC-PRO313NF | In distribution | |
| MSC-SP3524 | In distribution | |
| MSC-IP-11.5 | In distribution | |
| DCT4013 | In distribution | |
| MSC-BAT-10 | In distribution | |
| MSC-PRO511 | In distribution | |
| ITT508 | In distribution | |
| ITT612F | In distribution | |
| MSC-SP3720 | In distribution | |
| MSC-PRO518 | In distribution | |
| DCR5008 | In distribution | |
| IBS20 | In distribution | |
| MSC-BAT-8.5 | In distribution | |
| MSC-PRO12D408 | In distribution | |
| ZYGEX-40 | In distribution | |
| IVM-EX5212D-6011 | In distribution | |
| IM-T4218-12d | In distribution | |
| MSC-SP3508 | In distribution | |
| MSC-SP3520 | In distribution | |
| ZYGIN-35 | In distribution | |
| IBS8.5 | In distribution | |
| MSC-SP5013 | In distribution | |
| ZYG-55-50N | In distribution | |
| ZYGEX-37.5 | In distribution | |
| ITC406F | In distribution | |
| MSC-BA7 | In distribution | |
| ZYG-55-47.5N | In distribution | |
| MSC-PRO12D313 | In distribution | |
| MSC-BAT-13 | In distribution | |
| DCR5013 | In distribution | |
| BBBS13 | In distribution | |
| IM-T4210 | In distribution | |
| BBBTI13 | In distribution | |
| ZYGON-40 | In distribution | |
| ZYGON-42.5 | In distribution | |
| MSC-PRO12D311 | In distribution | |
| MSC-PRO318NF | In distribution | |
| DR-SP3720 | In distribution | |
| IVM-EX3012D-3711 | In distribution | |
| MSC-SP5016 | In distribution | |
| MAX-8-13 | In distribution | |
| IVM-EX3012D-3713 | In distribution | |
| IVM-DC40-5008 | In distribution | |
| IVM-EX35-4515 | In distribution | |
| MSC-SP5008 | In distribution | |
| ZYGON-32.5 | In distribution | |
| IV-EX3012D-3713 | In distribution | |
| MSC-PRO411 | In distribution | |
| MSC-IBS11.5 | In distribution | |
| DCR5015 | In distribution | |
| ZYG-55-55N | In distribution | |
| BATI10 | In distribution | |
| ZYG-55-40N | In distribution | |
| MSC-SP4020 | In distribution | |
| ZYGAN-47.5 | In distribution | |
| ZYG-55-45N | In distribution | |
| MSC-SP4511 | In distribution | |
| MSC-PRO313 | 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 |
| 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 |
| Ankylos® | Dentsply Implants Manufacturing GmbH | 391 |
Showing 12 of 2,762. All products under Implant, Endosseous, Root-Form
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232726 | 2024-04-01 |
| K232418 | 2023-12-01 |
| K222457 | 2023-03-06 |
| K222497 | 2022-11-09 |
| K192651 | 2020-05-07 |
| K191054 | 2019-12-09 |
| K181850 | 2018-11-14 |
| K180465 | 2018-09-06 |
| K173706 | 2018-06-08 |
| K173343 | 2018-02-27 |
| K163634 | 2017-11-06 |
| K163060 | 2017-06-13 |
| K093562 | 2010-10-14 |
| K082651 | 2008-12-22 |
| K071161 | 2007-11-16 |
| K070841 | 2007-06-21 |
| K070905 | 2007-05-24 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Keystone Dental Inc. | 510(k) number | 2017-06-16 | Class II | Unknown/Undetermined by firm | An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label. | 72 | 2019-04-16 |
| Southern Implants (PTY) Ltd | 510(k) number | 2015-01-23 | Class II | Mixed-up of materials/components | Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant, 9mm diameter, 7mm length. And vice versa. | 130 units | 2015-05-20 |
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.