InVu Ceramic Brackets 297-169
InVu Ceramic Brackets 297-169 is a Class II device made by Tp Orthodontics, Inc., cleared under FDA 510(k) K950992 on 3 May 1995 and listed in FDA GUDID since 20 Feb 2019 (UDI-DI 00192029001554), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00192029001554 | Date20 Feb 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK950992 | Date3 May 1995 | StatusActive |
Official records
- AccessGUDID record 00192029001554
- FDA 510(k) database K950992
Across registries
- FDA 510(k) K950992 decided 3 May 1995 Active
- FDA GUDID UDI-DI 00192029001554 listed 20 Feb 2019 Listed
Timeline
- Cleared FDA 510(k) K950992
- Listed FDA GUDID 00192029001554
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- InVu Ceramic Brackets
- Generic name
- Orthodontic bracket, ceramic
- Model / reference
- 297-169
- Description
- Lower Left/Right Anteriors -1 Torque, 0 Tip Without Vertical Slot, Bondable 0.46mm (.018")
- Primary DI / UDI-DI
- 00192029001554
- 510(k) Number
- FDA product code
- NJM
- GMDN term
- Orthodontic bracket, ceramic
- Device class
- Class II
- Regulation number
- 872.5470
- GUDID distribution status
- In Commercial Distribution