Leone SPA
BKT BIC Ceram 22 Logic Step T-12A+2 BH R
1manufacturer
121catalogue numbers in this listing
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 | Leone SPA, Italy |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K091702 |
| Record published | 2017-11-07 |
| Record revised | 2018-07-06 (version 3) |
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 |
|---|---|---|
| F5740-06 | In distribution | |
| F5706-20 | In distribution | |
| F5714-06 | In distribution | |
| F5721-02 | In distribution | |
| F5883-02 | In distribution | |
| F5751-02 | In distribution | |
| F5743-03 | In distribution | |
| F5741-02 | In distribution | |
| F5920-06 | In distribution | |
| F5751-03 | In distribution | |
| F5914-06 | In distribution | |
| F5753-06 | In distribution | |
| F5806-80 | In distribution | |
| F5775-06 | In distribution | |
| F5906-21 | In distribution | |
| F5906-20 | In distribution | |
| F5920-81 | In distribution | |
| F5749-02 | In distribution | |
| F5885-06 | In distribution | |
| F5912-21 | In distribution | |
| F5740-07 | In distribution | |
| F5710-80 | In distribution | |
| F5889-02 | In distribution | |
| F5912-20 | In distribution | |
| F5921-02 | In distribution | |
| F5913-16 | In distribution | |
| F5913-03 | In distribution | |
| F5885-07 | In distribution | |
| F5883-06 | In distribution | |
| F5743-06 | In distribution | |
| F5781-02 | In distribution | |
| F5914-16 | In distribution | |
| F5752-02 | In distribution | |
| F5742-03 | In distribution | |
| F5915-16 | In distribution | |
| F5810-80 | In distribution | |
| F5913-12 | In distribution | |
| F5719-02 | In distribution | |
| F5920-07 | In distribution | |
| F5782-02 | In distribution | |
| F5884-07 | In distribution | |
| F5920-21 | In distribution | |
| F5743-07 | In distribution | |
| F5820-80 | In distribution | |
| F5812-80 | In distribution | |
| F5913-06 | In distribution | |
| F5720-20 | In distribution | |
| F5882-02 | In distribution | |
| F5881-03 | In distribution | |
| F5920-82 | In distribution | |
| F5881-02 | In distribution | |
| F5715-06 | In distribution | |
| F5781-03 | In distribution | |
| F5773-03 | In distribution | |
| F5750-91 | In distribution | |
| F5713-06 | In distribution | |
| F5720-05 | In distribution | |
| F5742-02 | In distribution | |
| F5773-07 | In distribution | |
| F5710-20 | In distribution | |
| F5921-03 | In distribution | |
| F5915-07 | In distribution | |
| F5750-05 | In distribution | |
| F5782-03 | In distribution | |
| F5913-17 | In distribution | |
| F5913-13 | In distribution | |
| F5752-03 | In distribution | |
| F5920-20 | In distribution | |
| F5722-02 | In distribution | |
| F5774-07 | In distribution | |
| F5913-02 | In distribution | |
| F5720-80 | In distribution | |
| F5719-03 | In distribution | |
| F5712-80 | In distribution | |
| F5921-13 | In distribution | |
| F5712-20 | In distribution | |
| F5775-07 | In distribution | |
| F5889-03 | In distribution | |
| F5773-06 | In distribution | |
| F5919-12 | In distribution | |
| F5706-80 | In distribution | |
| F5883-07 | In distribution | |
| F5722-03 | In distribution | |
| F5721-03 | In distribution | |
| F5920-05 | In distribution | |
| F5919-13 | In distribution | |
| F5713-02 | In distribution | |
| F5919-02 | In distribution | |
| F5780-905 | In distribution | |
| F5715-07 | In distribution | |
| F5774-06 | In distribution | |
| F5922-03 | In distribution | |
| F5773-02 | In distribution | |
| F5922-13 | In distribution | |
| F5713-07 | In distribution | |
| F5753-03 | In distribution | |
| F5914-17 | In distribution | |
| F5913-07 | In distribution | |
| F5915-06 | In distribution | |
| F5740-91 | In distribution | |
| F5749-03 | In distribution | |
| F5753-07 | In distribution | |
| F5914-07 | In distribution | |
| F5915-17 | In distribution | |
| F5713-03 | In distribution | |
| F5919-03 | In distribution | |
| F5780-05 | In distribution | |
| F5714-07 | In distribution | |
| F5741-03 | In distribution | |
| F5921-12 | In distribution | |
| F5882-03 | In distribution | |
| F5884-06 | In distribution | |
| F5922-02 | In distribution | |
| F5910-21 | In distribution | |
| F5779-02 | In distribution | |
| F5753-02 | In distribution | |
| F5743-02 | In distribution | |
| F5922-12 | In distribution | |
| F5883-03 | In distribution | |
| F5910-20 | In distribution | |
| F5779-03 | 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
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.