Optyc
Optyc Roth CUS HK 0T +11A 022 UR
1manufacturer
24catalogue numbers in this listing
1510(k) clearance
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 | Lancer Orthodontics, Inc., United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Record published | 2016-12-30 |
| Record revised | 2022-04-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 246-502 | In distribution | |
| 246-501 | In distribution | |
| 246-521 | In distribution | |
| 246-551 | In distribution | |
| 246-422 | In distribution | |
| 246-512 | In distribution | |
| 246-573 | In distribution | |
| 246-541 | In distribution | |
| 246-511 | In distribution | |
| 246-401 | In distribution | |
| 246-412 | In distribution | |
| 246-473 | In distribution | |
| 246-533 | In distribution | |
| 246-441 | In distribution | |
| 246-433 | In distribution | |
| 246-421 | In distribution | |
| 246-463 | In distribution | |
| 246-411 | In distribution | |
| 246-563 | In distribution | |
| 246-402 | In distribution | |
| 246-451 | In distribution | |
| 246-452 | In distribution | |
| 246-552 | In distribution | |
| 246-522 | 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 |
|---|---|
| K902075 | 1990-08-06 |
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.