Vatech Clismile
Vatech Clismile is a self-ligating orthodontic bracket range that transfers archwire force to natural teeth. Its ceramic bracket configuration combines an alumina body with a nickel-cobalt…
Vatech Clismile is a self-ligating orthodontic bracket range that transfers archwire force to natural teeth. Its ceramic bracket configuration combines an alumina body with a nickel-cobalt alloy cap that retains the wire.
The cap provides the bracket’s self-ligating connection, while the bracket shape determines how force is transmitted to the tooth. The ceramic body and metal cap have separate structural roles.
Listed Item
This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
Bracket Configurations
The range includes MBT and ROTH designs with or without hooks and a 0.022 inch wire slot. The stated orthodontic use excludes mandibular bicuspid teeth, so the ceramic configuration is not a universal bracket for every tooth position.
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 | Rayence Co., Ltd., South Korea |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Manufacturer |
| 510(k) | K220689 |
| Record published | 2022-05-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02-1253 | In distribution | |
| 02-1203 | In distribution | |
| 11-1214 | In distribution | |
| 11-1232 | In distribution | |
| 11-1241 | In distribution | |
| 12-1211 | In distribution | |
| 11-1213 | In distribution | |
| 02-1255 | In distribution | |
| 12-1214 | In distribution | |
| 11-1215 | In distribution | |
| 11-1243 | In distribution | |
| 11-1222 | In distribution | |
| 01-1203 | In distribution | |
| 12-1224 | In distribution | |
| 12-1213 | In distribution | |
| 12-1225 | In distribution | |
| 11-1221 | In distribution | |
| 11-1212 | In distribution | |
| 01-1233 | In distribution | |
| 01-1250 | In distribution | |
| 11-1231 | In distribution | |
| 12-1221 | In distribution | |
| 12-1231 | In distribution | |
| 01-1253 | In distribution | |
| 12-1212 | In distribution | |
| 12-1233 | In distribution | |
| 11-1242 | In distribution | |
| 01-1255 | In distribution | |
| 11-1223 | In distribution | |
| 12-1241 | In distribution | |
| 02-1250 | In distribution | |
| 12-1222 | In distribution | |
| 02-1230 | In distribution | |
| 11-1225 | In distribution | |
| 12-1215 | In distribution | |
| 01-1230 | In distribution | |
| 12-1232 | In distribution | |
| 02-1205 | In distribution | |
| 11-1211 | In distribution | |
| 11-1233 | In distribution | |
| 12-1242 | In distribution | |
| 02-1233 | In distribution | |
| 12-1223 | In distribution | |
| 11-1224 | In distribution | |
| 12-1243 | In distribution | |
| 01-1205 | 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 |
|---|---|
| K220689 | 2022-05-06 |
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.