Integrity NTE-11
Integrity NTE-11 is a Class I device made by Osseo Scientific, LLC, cleared under FDA 510(k) K070155 on 25 Jan 2007 and listed in FDA GUDID since 13 Jul 2022 (UDI-DI 00850012724162), 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 | Number00850012724162 | Date13 Jul 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK070155 | Date25 Jan 2007 | StatusActive |
Official records
- AccessGUDID record 00850012724162
- FDA 510(k) database K070155
Across registries
- FDA 510(k) K070155 decided 25 Jan 2007 Active
- FDA GUDID UDI-DI 00850012724162 listed 13 Jul 2022 Listed
Timeline
- Cleared FDA 510(k) K070155
- Listed FDA GUDID 00850012724162
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Integrity
- Generic name
- Dental precision attachment fitting/adjustment tool
- Model / reference
- NTE-11
- Primary DI / UDI-DI
- 00850012724162
- 510(k) Number
- FDA product code
- EFB
- GMDN term
- Dental precision attachment fitting/adjustment tool
- Device class
- Class I
- Regulation number
- 872.4200
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Dental precision attachment fitting/adjustment tool.