TipEdge PLUS Ceramic Readi-Base Bracket 297-604
TipEdge PLUS Ceramic Readi-Base Bracket 297-604 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 12 Feb 2019 (UDI-DI 00192029005712), 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 | Number00192029005712 | Date12 Feb 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK950992 | Date3 May 1995 | StatusActive |
Official records
- AccessGUDID record 00192029005712
- FDA 510(k) database K950992
Across registries
- FDA 510(k) K950992 decided 3 May 1995 Active
- FDA GUDID UDI-DI 00192029005712 listed 12 Feb 2019 Listed
Timeline
- Cleared FDA 510(k) K950992
- Listed FDA GUDID 00192029005712
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TipEdge PLUS Ceramic Readi-Base Bracket
- Generic name
- Orthodontic bracket, ceramic
- Model / reference
- 297-604
- Primary DI / UDI-DI
- 00192029005712
- 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
Similar devices in this category
Other devices filed under Orthodontic bracket, ceramic.