Dentin Prestige Implants
Dentin Prestige implants are two-stage dental implants with an internal hexagonal connection. They are placed in the upper or lower jaw to support prosthetic teeth and form one implant line…
Dentin Prestige implants are two-stage dental implants with an internal hexagonal connection. They are placed in the upper or lower jaw to support prosthetic teeth and form one implant line within the wider DENTIN Dental Implants System.
The Prestige range includes diameters of 3.75, 4.2, 5 and 6 mm, with implant lengths varying by diameter. These are separate implant bodies used with the system’s healing and restorative components.
Listed Item
Prestige dental implant D=5.0mm, L=11.5mm
Related Components
The wider DENTIN system includes cover screws, healing caps, abutments and superstructures, together with impression-transfer components and surgical instruments. Prestige belongs to the two-stage range; the separate ONEPIECE line combines a different one-stage implant configuration.
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 | Dentin Implants Technologies Ltd., Israel |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K120530 |
| Record published | 2018-09-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PPR-1042 | In distribution | |
| PPR-1360 | In distribution | |
| PPR-1150 | In distribution | |
| PPR-1338 | In distribution | |
| PPR-0838 | In distribution | |
| PPR-1038 | In distribution | |
| PPR-0850 | In distribution | |
| PPR-1060 | In distribution | |
| PPR-0750 | In distribution | |
| PPR-1342 | In distribution | |
| PPR-1650 | In distribution | |
| PPR-1642 | In distribution | |
| PPR-1160 | In distribution | |
| PPR-1142 | In distribution | |
| PPR-0860 | In distribution | |
| PPR-1138 | In distribution | |
| PPR-0760 | In distribution | |
| PPR-1050 | In distribution | |
| PPR-0842 | In distribution | |
| PPR-1638 | In distribution | |
| PPR-0660 | In distribution | |
| PPR-1350 | In distribution | |
| PPR-0650 | In distribution |
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 |
|---|---|
| K120530 | 2012-07-05 |
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.