ClearVu Mini Ceramic Brackets
Upper 5-5 Cuspid/Bicuspid W/Hook Clear Vu̫ Mini Ceramic All Remaining Brackets Lower 5-5 Nu-Edge̫ Metal 0.46 mm (.018") Bondable
1manufacturer
70catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi TP Orthodontics Material Co., Ltd. | Wuxi | Jiangsu | Repacker / relabeller | 9 |
Record
| Listed by | TP Orthodontics, Inc., United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K950992 |
| Record published | 2019-02-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 27 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 297-426CV | In distribution | |
| 297-102CV | In distribution | |
| 297-289CV | In distribution | |
| 297-428CV | In distribution | |
| 297-421CV | In distribution | |
| 297-285CV | In distribution | |
| 297-382CV | In distribution | |
| 297-150CV | In distribution | |
| 297-291CV | In distribution | |
| 297-410CV | In distribution | |
| 297-446CV | In distribution | |
| 297-169CV | In distribution | |
| 297-317CV | In distribution | |
| 297-103CV | In distribution | |
| 297-420CV | In distribution | |
| 297-429CV | In distribution | |
| 297-354CV | In distribution | |
| 297-310CV | In distribution | |
| 297-139CV | In distribution | |
| 297-383CV | In distribution | |
| 297-160CV | In distribution | |
| 297-295CV | In distribution | |
| 297-406CV | In distribution | |
| 297-153CV | In distribution | |
| 297-299CV | In distribution | |
| 297-287CV | In distribution | |
| 297-312CV | In distribution | |
| 297-294CV | In distribution | |
| 297-447CV | In distribution | |
| 297-152CV | In distribution | |
| 297-100CV | In distribution | |
| 297-490CV | In distribution | |
| 297-495CV | In distribution | |
| 297-316CV | In distribution | |
| 297-408CV | In distribution | |
| 297-407CV | In distribution | |
| 297-427CV | In distribution | |
| 297-101CV | In distribution | |
| 297-151CV | In distribution | |
| 297-292CV | In distribution | |
| 297-284CV | In distribution | |
| 297-419CV | In distribution | |
| 297-290CV | In distribution | |
| 297-286CV | In distribution | |
| 297-448CV | In distribution | |
| 297-409CV | In distribution | |
| 297-380CV | In distribution | |
| 297-148CV | In distribution | |
| 297-051CV | In distribution | |
| 297-288CV | In distribution | |
| 297-298CV | In distribution | |
| 297-315CV | In distribution | |
| 297-138CV | In distribution | |
| 297-149CV | In distribution | |
| 297-297CV | In distribution | |
| 297-031CV | In distribution | |
| 297-313CV | In distribution | |
| 297-411CV | In distribution | |
| 297-405CV | In distribution | |
| 297-056CV | In distribution | |
| 297-293CV | In distribution | |
| 297-404CV | In distribution | |
| 297-311CV | In distribution | |
| 297-381CV | In distribution | |
| 297-036CV | In distribution | |
| 297-296CV | In distribution | |
| 297-355CV | In distribution | |
| 297-449CV | In distribution | |
| 297-314CV | In distribution | |
| 297-418CV | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QuicKlear® | Forestadent Bernhard Förster GmbH | 841 |
| Bracket, Ceramic, Orthodontic | Flexmedics | 600 |
| Experience | GC Orthodontics America Inc. | 500 |
| TruKlear | Forestadent Bernhard Förster GmbH | 401 |
| Chic | GC Orthodontics America Inc. | 348 |
| Bracket, Ceramic, Orthodontic | Forestadent Bernhard Förster GmbH | 342 |
| IN-Ovation® C | Dentsply Sirona Orthodontics Inc. | 327 |
| Intrigue | Lancer Orthodontics, Inc. | 253 |
| Empower Clear | American Orthodontics | 250 |
| Empower Clear Bracket | American Orthodontics | 250 |
| InVu Ceramic Brackets | TP Orthodontics, Inc. | 226 |
| RadiancePlus | American Orthodontics | 179 |
Showing 12 of 399. All products under Bracket, Ceramic, Orthodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111234 | 2011-05-13 |
| K950992 | 1995-05-03 |
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.