TipEdge Plus Ceramic Brackets
.022" Lower Bicuspid - CCW 4.5 MM, Purple I.D. -20 Torque, 0 TIP
1manufacturer
27catalogue numbers in this listing
2510(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 | TP Orthodontics, Inc., United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K950992 |
| Record published | 2019-02-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 27 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 297-652 | In distribution | |
| 297-670 | In distribution | |
| 297-669 | In distribution | |
| 297-673 | In distribution | |
| 297-656 | In distribution | |
| 297-659 | In distribution | |
| 297-648 | In distribution | |
| 297-642 | In distribution | |
| 297-672 | In distribution | |
| 297-646 | In distribution | |
| 297-647 | In distribution | |
| 297-655 | In distribution | |
| 297-671 | In distribution | |
| 297-660 | In distribution | |
| 297-641 | In distribution | |
| 297-651 | In distribution | |
| 297-644 | In distribution | |
| 297-645 | In distribution | |
| 297-653 | In distribution | |
| 297-661 | In distribution | |
| 297-668 | In distribution | |
| 297-667 | In distribution | |
| 297-674 | In distribution | |
| 297-640 | In distribution | |
| 297-654 | In distribution | |
| 297-643 | In distribution | |
| 297-662 | 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 |
|---|---|
| K111234 | 2011-05-13 |
| K950992 | 1995-05-03 |
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.