2040 Ceramic Brackets
Cosmetic 20/40 Single Width Lower ANT 018 T=0 A=0 R=0
1manufacturer
112catalogue numbers in this listing
3510(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 | American Orthodontics, United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K922499 |
| Record published | 2016-11-09 |
| Record revised | 2025-06-19 (version 6) |
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 |
|---|---|---|
| 002-1036B | In distribution | |
| 002-2302 | In distribution | |
| 002-1011B | In distribution | |
| 002-2314 | In distribution | |
| 002-2425B | In distribution | |
| 002-2334B | In distribution | |
| 002-2321 | In distribution | |
| 002-1028B | In distribution | |
| 002-2328B | In distribution | |
| 002-1008 | In distribution | |
| 002-1008B | In distribution | |
| 002-1027B | In distribution | |
| 002-2326 | In distribution | |
| 002-2327 | In distribution | |
| 002-1055 | In distribution | |
| 002-1052 | In distribution | |
| 002-1013 | In distribution | |
| 002-2337B | In distribution | |
| 002-1036 | In distribution | |
| 002-2333B | In distribution | |
| 002-1065 | In distribution | |
| 002-2331B | In distribution | |
| 002-1063 | In distribution | |
| 002-2311B | In distribution | |
| 002-1025 | In distribution | |
| 002-2337 | In distribution | |
| 002-2310 | In distribution | |
| 002-2334 | In distribution | |
| 002-1061 | In distribution | |
| 002-1062 | In distribution | |
| 002-2317B | In distribution | |
| 002-2312B | In distribution | |
| 002-1028 | In distribution | |
| 002-1016B | In distribution | |
| 002-2324 | In distribution | |
| 002-2426B | In distribution | |
| 002-1051 | In distribution | |
| 002-1035B | In distribution | |
| 002-1031B | In distribution | |
| 002-2329B | In distribution | |
| 002-2307 | In distribution | |
| 002-2318 | In distribution | |
| 002-2315B | In distribution | |
| 002-1007 | In distribution | |
| 002-1013B | In distribution | |
| 002-1005B | In distribution | |
| 002-2316 | In distribution | |
| 002-2308B | In distribution | |
| 002-2332B | In distribution | |
| 002-1021 | In distribution | |
| 002-1032B | In distribution | |
| 002-1002 | In distribution | |
| 002-2305 | In distribution | |
| 002-1025B | In distribution | |
| 002-1014 | In distribution | |
| 002-1033B | In distribution | |
| 002-1022 | In distribution | |
| 002-1030 | In distribution | |
| 002-1035 | In distribution | |
| 002-2309B | In distribution | |
| 002-1034 | In distribution | |
| 002-2318B | In distribution | |
| 002-2316B | In distribution | |
| 002-2315 | In distribution | |
| 002-1001 | In distribution | |
| 002-2326B | In distribution | |
| 002-2325B | In distribution | |
| 002-1012B | In distribution | |
| 002-2336B | In distribution | |
| 002-2303 | In distribution | |
| 002-1004 | In distribution | |
| 002-2323 | In distribution | |
| 002-2325 | In distribution | |
| 002-2335 | In distribution | |
| 002-2405B | In distribution | |
| 002-2338B | In distribution | |
| 002-1015 | In distribution | |
| 002-2336 | In distribution | |
| 002-1010 | In distribution | |
| 002-1027 | In distribution | |
| 002-1053 | In distribution | |
| 002-2317 | In distribution | |
| 002-2406B | In distribution | |
| 002-1032 | In distribution | |
| 002-2301 | In distribution | |
| 002-1033 | In distribution | |
| 002-1011 | In distribution | |
| 002-1026B | In distribution | |
| 002-1007B | In distribution | |
| 002-1054 | In distribution | |
| 002-2304 | In distribution | |
| 002-1034B | In distribution | |
| 002-1003 | In distribution | |
| 002-1024 | In distribution | |
| 002-2338 | In distribution | |
| 002-1031 | In distribution | |
| 002-2306 | In distribution | |
| 002-2322 | In distribution | |
| 002-1014B | In distribution | |
| 002-2335B | In distribution | |
| 002-1016 | In distribution | |
| 002-1006 | In distribution | |
| 002-1026 | In distribution | |
| 002-1023 | In distribution | |
| 002-1006B | In distribution | |
| 002-1012 | In distribution | |
| 002-2330 | In distribution | |
| 002-1015B | In distribution | |
| 002-2313 | In distribution | |
| 002-1005 | In distribution | |
| 002-1064 | In distribution | |
| 002-2333 | 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 |
|---|---|
| K232011 | 2023-07-07 |
| K122753 | 2012-12-14 |
| K080749 | 2008-08-04 |
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.