UV Active Implant System
UV Active Implant System uses titanium dental fixtures to support single- or multiple-tooth restorations in the upper or lower jaw. Fixtures have a sandblasted and acid-etched surface and…
UV Active Implant System uses titanium dental fixtures to support single- or multiple-tooth restorations in the upper or lower jaw. Fixtures have a sandblasted and acid-etched surface and are accompanied by compatible abutments, cylinders and screws.
Fixture diameters span 3.0 to 6.4 mm and lengths 7 to 13 mm. The implants are supplied gamma-sterilized; abutments, screws and cylinders are supplied nonsterile for user steam sterilization.
Listed Item
Ø3.3X11.5mm
Diameter-Specific Loading
Narrow 3.0 and 3.3 mm implants are limited to upper lateral incisors and lower incisors with delayed loading. Regular 3.8 to 5.5 mm implants may support immediate loading with adequate stability and occlusal conditions. Wide 5.9 to 6.4 mm implants are for molars with delayed loading.
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 | DIO Corporation, South Korea |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K182194 |
| Record published | 2020-01-10 |
| Record revised | 2024-01-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UF(II) 5007UV3 | In distribution | |
| UF(II) 4008UV3 | In distribution | |
| UF(II)N 3311UV3 | In distribution | |
| UF(II) 6507UV3 | In distribution | |
| UF(II) 6007UV3 | In distribution | |
| UF(II) 5008UV3 | In distribution | |
| UF(II) 4011UV3 | In distribution | |
| UF(II) 6510UV3 | In distribution | |
| UF(II)N 3313UV3 | In distribution | |
| UF(II) 3808UV3 | In distribution | |
| UF(II) 5507UV3 | In distribution | |
| UF(II) 6508UV3 | In distribution | |
| UF(II)N 3011UV3 | In distribution | |
| UF(II) 5013UV3 | In distribution | |
| UF(II)N 3310UV3 | In distribution | |
| UF(II) 4010UV3 | In distribution | |
| UF(II) 3810UV3 | In distribution | |
| UF(II) 4513UV3 | In distribution | |
| UF(II) 5508UV3 | In distribution | |
| UF(II) 3813UV3 | In distribution | |
| UF(II) 6010UV3 | In distribution | |
| UF(II) 3811UV3 | In distribution | |
| UF(II) 6011UV3 | In distribution | |
| UF(II) 6008UV3 | In distribution | |
| UF(II) 5510UV3 | In distribution | |
| UF(II) 5513UV3 | In distribution | |
| UF(II)N 3010UV3 | In distribution | |
| UF(II)N 3013UV3 | In distribution | |
| UF(II) 4013UV3 | In distribution | |
| UF(II) 4508UV3 | In distribution | |
| UF(II) 5010UV3 | In distribution | |
| UF(II)N 3308UV3 | In distribution | |
| UF(II)N 3008UV3 | In distribution | |
| UF(II) 6013UV3 | In distribution | |
| UF(II) 5511UV3 | In distribution | |
| UF(II) 6511UV3 | In distribution | |
| UF(II) 5011UV3 | In distribution | |
| UF(II) 4511UV3 | In distribution | |
| UF(II) 4510UV3 | In distribution | |
| UF(II) 4507UV3 | In distribution | |
| UF(II) 6513UV3 | 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 |
|---|---|
| K182194 | 2018-12-14 |
| K173975 | 2018-06-01 |
| K170608 | 2018-03-30 |
| K161987 | 2017-02-21 |
| K122519 | 2013-05-21 |
| K112746 | 2011-10-21 |
| K100100 | 2010-11-10 |
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.