Ufit Dental Implant
The Ufit Dental Implant is placed in the upper or lower jaw to support replacement of one or more missing teeth. It is intended for partially or fully edentulous patients and supports…
The Ufit Dental Implant is placed in the upper or lower jaw to support replacement of one or more missing teeth. It is intended for partially or fully edentulous patients and supports single or multiple restorations, including fixed bridgework and overdentures. Loading is delayed until after a conventional healing period.
The fixture is made from Ti-6Al-4V ELI titanium alloy and has a surface treated with resorbable blasted media. It forms the implanted support for the system’s restorative abutments and associated prosthesis. Single-stage or two-stage surgical procedures may be used.
Sizes and Supply
The system includes fixture diameters from 3.8 to 7.0 mm and lengths from 7 to 14.5 mm. Fixtures are supplied sterile following gamma irradiation and are intended for single use.
7manufacturers in China registered for this device type
108catalogue numbers in this listing
1510(k) clearance
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 | T. Strong Inc., South Korea |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Manufacturer |
| 510(k) | K132956 |
| Record published | 2026-05-28 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 3.9 to 7 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6513MT | Outer Diameter 6.5 mm | In distribution |
| 70115T | Outer Diameter 7.0 mm | In distribution |
| 6507MT | Outer Diameter 6.5 mm | In distribution |
| 5010T | Outer Diameter 5.0 mm | In distribution |
| 6507T | Outer Diameter 6.5 mm | In distribution |
| 3913T | Outer Diameter 3.9 mm | In distribution |
| 45115MT | Outer Diameter 4.5 mm | In distribution |
| 6515T | Outer Diameter 6.5 mm | In distribution |
| 5515T | Outer Diameter 5.5 mm | In distribution |
| 60085MT | Outer Diameter 6.0 mm | In distribution |
| 7013MT | Outer Diameter 7.0 mm | In distribution |
| 45085MT | Outer Diameter 4.5 mm | In distribution |
| 7007MT | Outer Diameter 7.0 mm | In distribution |
| 4110T | Outer Diameter 4.1 mm | In distribution |
| 4015T | Outer Diameter 4.0 mm | In distribution |
| 4013T | Outer Diameter 4.0 mm | In distribution |
| 4010MT | Outer Diameter 4.0 mm | In distribution |
| 4113MT | Outer Diameter 4.1 mm | In distribution |
| 60115MT | Outer Diameter 6.0 mm | In distribution |
| 40115T | Outer Diameter 4.0 mm | In distribution |
| 5015MT | Outer Diameter 5.0 mm | In distribution |
| 6515MT | Outer Diameter 6.5 mm | In distribution |
| 6015T | Outer Diameter 6.0 mm | In distribution |
| 39085T | Outer Diameter 3.9 mm | In distribution |
| 3915T | Outer Diameter 3.9 mm | In distribution |
| 6015MT | Outer Diameter 6.0 mm | In distribution |
| 55085T | Outer Diameter 5.5 mm | In distribution |
| 4107MT | Outer Diameter 4.1 mm | In distribution |
| 50085MT | Outer Diameter 5.0 mm | In distribution |
| 7010T | Outer Diameter 7.0 mm | In distribution |
| 6513T | Outer Diameter 6.5 mm | In distribution |
| 50115MT | Outer Diameter 5.0 mm | In distribution |
| 5007T | Outer Diameter 5.0 mm | In distribution |
| 39115T | Outer Diameter 3.9 mm | In distribution |
| 3913MT | Outer Diameter 3.9 mm | In distribution |
| 70085T | Outer Diameter 7.0 mm | In distribution |
| 4507MT | Outer Diameter 4.5 mm | In distribution |
| 40085T | Outer Diameter 4.0 mm | In distribution |
| 5513T | Outer Diameter 5.5 mm | In distribution |
| 5013MT | Outer Diameter 5.0 mm | In distribution |
| 5515MT | Outer Diameter 5.5 mm | In distribution |
| 7015T | Outer Diameter 7.0 mm | In distribution |
| 5507MT | Outer Diameter 5.5 mm | In distribution |
| 4110MT | Outer Diameter 4.1 mm | In distribution |
| 4513T | Outer Diameter 4.5 mm | In distribution |
| 3910MT | Outer Diameter 3.9 mm | In distribution |
| 3907T | Outer Diameter 3.9 mm | In distribution |
| 65115T | Outer Diameter 6.5 mm | In distribution |
| 7015MT | Outer Diameter 7.0 mm | In distribution |
| 6013T | Outer Diameter 6.0 mm | In distribution |
| 4113T | Outer Diameter 4.1 mm | In distribution |
| 4515MT | Outer Diameter 4.5 mm | In distribution |
| 40115MT | Outer Diameter 4.0 mm | In distribution |
| 5015T | Outer Diameter 5.0 mm | In distribution |
| 3910T | Outer Diameter 3.9 mm | In distribution |
| 55115MT | Outer Diameter 5.5 mm | In distribution |
| 4515T | Outer Diameter 4.5 mm | In distribution |
| 6510T | Outer Diameter 6.5 mm | In distribution |
| 4013MT | Outer Diameter 4.0 mm | In distribution |
| 4015MT | Outer Diameter 4.0 mm | In distribution |
| 41085T | Outer Diameter 4.1 mm | In distribution |
| 50085T | Outer Diameter 5.0 mm | In distribution |
| 45115T | Outer Diameter 4.5 mm | In distribution |
| 4513MT | Outer Diameter 4.5 mm | In distribution |
| 4007T | Outer Diameter 4.0 mm | In distribution |
| 60085T | Outer Diameter 6.0 mm | In distribution |
| 55085MT | Outer Diameter 5.5 mm | In distribution |
| 7007T | Outer Diameter 7.0 mm | In distribution |
| 7010MT | Outer Diameter 7.0 mm | In distribution |
| 4510MT | Outer Diameter 4.5 mm | In distribution |
| 70085MT | Outer Diameter 7.0 mm | In distribution |
| 5507T | Outer Diameter 5.5 mm | In distribution |
| 6007MT | Outer Diameter 6.0 mm | In distribution |
| 3915MT | Outer Diameter 3.9 mm | In distribution |
| 6010MT | Outer Diameter 6.0 mm | In distribution |
| 45085T | Outer Diameter 4.5 mm | In distribution |
| 4115MT | Outer Diameter 4.1 mm | In distribution |
| 5510T | Outer Diameter 5.5 mm | In distribution |
| 5513MT | Outer Diameter 5.5 mm | In distribution |
| 5010MT | Outer Diameter 5.0 mm | In distribution |
| 70115MT | Outer Diameter 7.0 mm | In distribution |
| 5013T | Outer Diameter 5.0 mm | In distribution |
| 3907MT | Outer Diameter 3.9 mm | In distribution |
| 7013T | Outer Diameter 7.0 mm | In distribution |
| 39085MT | Outer Diameter 3.9 mm | In distribution |
| 65115MT | Outer Diameter 6.5 mm | In distribution |
| 65085T | Outer Diameter 6.5 mm | In distribution |
| 4115T | Outer Diameter 4.1 mm | In distribution |
| 4507T | Outer Diameter 4.5 mm | In distribution |
| 60115T | Outer Diameter 6.0 mm | In distribution |
| 39115MT | Outer Diameter 3.9 mm | In distribution |
| 40085MT | Outer Diameter 4.0 mm | In distribution |
| 6010T | Outer Diameter 6.0 mm | In distribution |
| 6013MT | Outer Diameter 6.0 mm | In distribution |
| 4510T | Outer Diameter 4.5 mm | In distribution |
| 5510MT | Outer Diameter 5.5 mm | In distribution |
| 5007MT | Outer Diameter 5.0 mm | In distribution |
| 50115T | Outer Diameter 5.0 mm | In distribution |
| 41115T | Outer Diameter 4.1 mm | In distribution |
| 6007T | Outer Diameter 6.0 mm | In distribution |
| 6510MT | Outer Diameter 6.5 mm | In distribution |
| 4010T | Outer Diameter 4.0 mm | In distribution |
| 41115MT | Outer Diameter 4.1 mm | In distribution |
| 55115T | Outer Diameter 5.5 mm | In distribution |
| 4007MT | Outer Diameter 4.0 mm | In distribution |
| 65085MT | Outer Diameter 6.5 mm | In distribution |
| 4107T | Outer Diameter 4.1 mm | In distribution |
| 41085MT | Outer Diameter 4.1 mm | 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 |
|---|---|
| K132956 | 2014-06-05 |
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.