MXi Tip-Edge Brackets
Upper Left Central with Vertical Slot +12 Torque, +5 Tip Oriented, 4 mm, Red 0.56 mm (.022")
1manufacturer
39catalogue 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 | 2019-02-15 |
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 |
|---|---|---|
| 298-820F | In distribution | |
| 298-836F | In distribution | |
| 298-831F | In distribution | |
| 298-832F | In distribution | |
| 298-826F | In distribution | |
| 298-803F | In distribution | |
| 298-845F | In distribution | |
| 298-822F | In distribution | |
| 298-821F | In distribution | |
| 298-818F | In distribution | |
| 298-808F | In distribution | |
| 298-811F | In distribution | |
| 298-825F | In distribution | |
| 298-839F | In distribution | |
| 298-810F | In distribution | |
| 298-816F | In distribution | |
| 298-804F | In distribution | |
| 298-837F | In distribution | |
| 298-842F | In distribution | |
| 298-830F | In distribution | |
| 298-829F | In distribution | |
| 298-844F | In distribution | |
| 298-817F | In distribution | |
| 298-814F | In distribution | |
| 298-835F | In distribution | |
| 298-823F | In distribution | |
| 298-840F | In distribution | |
| 298-828F | In distribution | |
| 298-833F | In distribution | |
| 298-824F | In distribution | |
| 298-815F | In distribution | |
| 298-827F | In distribution | |
| 298-819F | In distribution | |
| 298-841F | In distribution | |
| 298-834F | In distribution | |
| 298-801F | In distribution | |
| 298-802F | In distribution | |
| 298-807F | In distribution | |
| 298-838F | 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.