Genesis Implant System
Genesis Implant System supports replacement teeth using fixtures placed in the upper or lower jawbone. The fixtures are Grade 4 titanium with straight or tapered bodies and an internal…
Genesis Implant System supports replacement teeth using fixtures placed in the upper or lower jawbone. The fixtures are Grade 4 titanium with straight or tapered bodies and an internal indexing connection.
Compatible abutments and restorative components connect the implant to the prosthesis. Most titanium abutments use Grade 5 alloy, while some component forms include plastic or gold-alloy parts.
Implant and Collar Surfaces
BioSpark treatment gives the implant a hydrophilic, nanorough surface enriched with calcium and phosphorus ions. The micro-roughened collar has an AnaTite treatment that produces a pink color. Different platforms and lengths identify the available fixture configurations.
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 | Keystone Dental Inc., United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K101545 |
| Record published | 2016-01-29 |
| Record revised | 2021-03-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2019-04-26 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G21130 | Outer Diameter 3.8-6.5mm | In distribution |
| G21135 | Outer Diameter 3.8-6.5mm | In distribution |
| G21133 | Outer Diameter 3.8-6.5mm | In distribution |
| G21131 | Outer Diameter 3.8-6.5mm | In distribution |
| G21139 | Outer Diameter 3.8-6.5mm | In distribution |
| G21146 | Outer Diameter 3.8-6.5mm | In distribution |
| G21137 | Outer Diameter 3.8-6.5mm | In distribution |
| G21145 | Outer Diameter 3.8-6.5mm | In distribution |
| G21153 | Outer Diameter 3.8-6.5mm | In distribution |
| G21138 | Outer Diameter 3.8-6.5mm | In distribution |
| G21142 | Outer Diameter 3.8-6.5mm | In distribution |
| G21151 | Outer Diameter 3.8-6.5mm | In distribution |
| G21144 | Outer Diameter 3.8-6.5mm | In distribution |
| G21140 | Outer Diameter 3.8-6.5mm | In distribution |
| G21150 | Outer Diameter 3.8-6.5mm | In distribution |
| G21132 | Outer Diameter 3.8-6.5mm | In distribution |
| G21147 | Outer Diameter 3.8-6.5mm | In distribution |
| G21152 | Outer Diameter 3.8-6.5mm | In distribution |
| G21050 | Outer Diameter 3.3-5.0mm | Withdrawn |
| G21052 | Outer Diameter 3.3-5.0mm | Withdrawn |
| G21051 | Outer Diameter 3.3-5.0mm | Withdrawn |
| G21053 | Outer Diameter 3.3-5.0mm | Withdrawn |
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 |
|---|---|
| K240966 | 2024-07-09 |
| K223814 | 2023-05-25 |
| K201334 | 2020-08-18 |
| K101545 | 2010-10-28 |
| K071070 | 2007-10-23 |
Recalls Naming This Product
1 recall names this product by its own identifier, 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 | 2018-03-13 | Class II | Error in labeling | The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette. | 19 | 2018-07-23 |
Recalls
9 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-02-22 | Class II | Process control | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature | 3 hex Driver | 2020-06-19 |
| 2019-02-22 | Class II | Process control | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature | 1 hex Driver | 2020-06-19 |
| 2019-02-22 | Class II | Process control | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature | 13 kits hex Driver | 2020-06-19 |
| 2019-02-22 | Class II | Process control | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature | 3 Hex Driver | 2020-06-19 |
| 2018-05-01 | Class II | Error in labeling | The implants are mislabeled. | 72 | 2018-09-14 |
| 2017-10-16 | Class III | Labeling mix-ups | A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve. | 55 | 2019-04-17 |
| 2017-08-25 | Class II | Error in labeling | The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06. | 20 | 2019-04-16 |
| 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 |
| 2017-03-09 | Class II | Labeling mix-ups | Straight PrimaConnex Implants contained Tapered PrimaConnex Implants | 59 units | 2017-07-05 |
| 2016-09-15 | Class II | Packaging process control | Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD) | 55 units | 2017-01-03 |
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.