FlexBracket
FlexBracket PCA UR7 022 -24 0 Hook
1manufacturer
29catalogue 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 | LightForce Orthodontics, United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Manufacturer |
| 510(k) | K232827 |
| Record published | 2025-10-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 09.01.25.PCA.FB.UR7.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.LL3.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.UL3.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.LR5.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.LL7.022 | 5 | In distribution | |
| 09.01.25.FB.PCA | In distribution | ||
| 09.01.25.PCA.FB.LL5.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.LR2.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.UR6.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.UL6.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.LL6.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.LL2.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.LL4.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.UR2.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.UL5.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.UR5.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.LR6.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.LR7.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.UL1.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.UR4.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.LR3.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.UL7.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.LL1.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.UL4.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.UL2.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.UR3.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.LR1.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.LR4.022 | 5 | In distribution | |
| 09.01.25.PCA.FB.UR1.022 | 5 | 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 |
|---|---|
| K232827 | 2023-09-14 |
| K222764 | 2022-09-14 |
| K200148 | 2020-02-21 |
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.