Alpha Dent Implants
Alpha Dent’s Superior Active and Active Bio Plus implants support tooth replacements using a conical threaded fixture. An internal cone and hexagon position the restorative connection above…
Alpha Dent’s Superior Active and Active Bio Plus implants support tooth replacements using a conical threaded fixture. An internal cone and hexagon position the restorative connection above the implant.
These fixtures are Grade 4 commercially pure titanium with a sandblasted, large-grit, acid-etched surface. Restorative abutments in the system use Ti-6Al-4V ELI alloy.
Listed Item
Alpha Dent Dental Implants System – Endosseous dental implant for surgical placement in the maxillary and/or mandibular arch, to support crowns, bridges, or overdentures. Conical-shaped implant with helical thread, SLA surface treatment, conical connection with internal hexagon. Material: Ti CP Grade 4 (ASTM F67). Sterile, gamma irradiation. Single use. WET packaging (NaCl 0.9%).
Wet-Packaged Configuration
The implant and cover screw are held in a protective titanium sleeve within a plastic vial containing 0.9% sodium chloride solution. The sealed vial and outer blister act as sterile barriers. These are the wet-packaged implant configurations within the broader Alpha Dent restoration family.
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 | Alpha Dent Implants Gmbh, Germany |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Manufacturer |
| 510(k) | K240435 |
| Record published | 2026-06-30 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Implant Integral Ø3.3 L16 | In distribution | |
| Implant Active Bio Plus Ø6.0 L11.5 | In distribution | |
| Implant Active Bio Plus Ø4.2 L13 | In distribution | |
| Implant Superior Active Ø4.0 L8.0 | In distribution | |
| Implant Active Bio Ø3.75 L13 | In distribution | |
| Implant Superior Active Ø3.5 L10 | In distribution | |
| Implant Active Bio Konus Ø 3.3 L 11.5 | In distribution | |
| Implant Superior Active Ø4.0 L13 | In distribution | |
| Implant Active Bio Ø3.75 L11.5 | In distribution | |
| Implant Superior Active Ø3.5 L11.5 | In distribution | |
| Implant Superior Active Ø5.5 L10 | In distribution | |
| Implant Active Bio Plus Ø5 L10 | In distribution | |
| Implant Active Bio Plus Ø5 L11.5 | In distribution | |
| Implant Superior Active Ø3.5 L8.0 | In distribution | |
| Implant Integral Ø3.3 L13 | In distribution | |
| Implant Superior Active Ø5.0 L11.5 | In distribution | |
| Implant Active Bio Ø3.75 L8 | In distribution | |
| Implant Superior Active Ø5.0 L8.0 | In distribution | |
| Implant Active Bio Plus Ø3.3 L13 | In distribution | |
| Implant Superior Active Ø4.0 L16 | In distribution | |
| Implant Active Bio Plus Ø4.2 L16 | In distribution | |
| Implant Superior Active Ø5.0 L10 | In distribution | |
| Implant Active Bio Plus Ø5 L13 | In distribution | |
| Implant Superior Active Ø4.5 L13 | In distribution | |
| Implant Superior Active Ø5.5 L11.5 | In distribution | |
| Implant Superior Active Ø3.5 L16 | In distribution | |
| Implant Active Bio Ø4.2 L11.5 | In distribution | |
| Implant Active Bio Plus Ø3.75 L16 | In distribution | |
| Titanium Abutment Konus 3 11mm | In distribution | |
| Implant Superior Active Ø4.5 L16 | In distribution | |
| Implant Active Bio Ø3.75 L10 | In distribution | |
| Implant Active Bio Plus Ø3.75 L8 | In distribution | |
| Implant Active Bio Plus Ø3.75 L13 | In distribution | |
| Implant Superior Active Ø6.0 L10 | In distribution | |
| Implant Active Bio Plus Ø6.0 L8 | In distribution | |
| Implant Superior Active Ø4.5 L8.0 | In distribution | |
| Implant Superior Active Ø5.0 L13 | In distribution | |
| Implant Superior Active Ø6.0 L11.5 | In distribution | |
| Implant Active Bio Ø4.2 L10 | In distribution | |
| Implant Active Bio Konus Ø 3.3 L 8 | In distribution | |
| Implant Active Bio Plus Ø3.3 L8 | In distribution | |
| Implant Active Bio Plus Ø5.0 L8 | In distribution | |
| Implant Active Bio Ø5 L13 | In distribution | |
| Implant Active Bio Ø5 L11.5 | In distribution | |
| Implant Superior Active Ø4.0 L10 | In distribution | |
| Implant Active Bio Konus Ø 3.3 L 10 | In distribution | |
| Implant Superior Active Ø4.5 L10 | In distribution | |
| Implant Active Bio Konus Ø 3.3 L 13 | In distribution | |
| Implant Superior Active Ø6.0 L8.0 | In distribution | |
| Implant Active Bio Plus Ø3.75 L11.5 | In distribution | |
| Implant Superior Active Ø3.5 L13 | In distribution | |
| Implant Superior Active Ø5.0 L16 | In distribution | |
| Implant Active Bio Plus Ø4.2 L11.5 | In distribution | |
| Implant Superior Active Ø6.0 L13 | In distribution | |
| Implant Active Bio Plus Ø3.75 L10 | In distribution | |
| Implant Superior Active Ø4.5 L11.5 | In distribution | |
| Implant Integral Ø3.3 L11.5 | In distribution | |
| Implant Superior Active Ø5.5 L8.0 | In distribution | |
| Implant Active Bio Ø4.2 L8 | In distribution | |
| Implant Active Bio Plus Ø3.3 L10 | In distribution | |
| Implant Active Bio Plus Ø4.2 L10 | In distribution | |
| Implant Active Bio Plus Ø6.0 L13 | In distribution | |
| Implant Active Bio Plus Ø6.0 L10 | In distribution | |
| Implant Active Bio Plus Ø3.3 L11.5 | In distribution | |
| Implant Active Bio Plus Ø4.2 L8 | In distribution | |
| Implant Active Bio Ø5 L8 | In distribution | |
| Implant Active Bio Ø4.2 L13 | In distribution | |
| Implant Superior Active Ø4.0 L11.5 | In distribution | |
| Implant Superior Active Ø5.5 L13 | In distribution | |
| Implant Active Bio Ø5 L10 | In distribution | |
| Implant Integral Ø3.3 L10 | 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 |
|---|---|
| K240435 | 2024-12-20 |
| K210499 | 2021-11-01 |
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.