PIVOT Medium Mint Prophy Pack Box 100 1100073
by Preventech
PIVOT Medium Mint Prophy Pack Box 100 1100073 is a Class I device made by Preventech, cleared under FDA 510(k) K100539 on 17 Jun 2010 (1 earlier submission) and listed in FDA GUDID since 13 Jun 2023 (UDI-DI D0241100073), active as of 22 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 | NumberD0241100073 | Date13 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK100539 | Date17 Jun 2010 | StatusActive |
Official records
- FDA 510(k) database K100539
- FDA 510(k) database K951016
Across registries
- FDA 510(k) K100539 decided 17 Jun 2010 Active
- FDA GUDID UDI-DI D0241100073 listed 13 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K951016
- Cleared FDA 510(k) K100539
- Listed FDA GUDID D0241100073
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PIVOT Medium Mint Prophy Pack Box 100
- Generic name
- Dental polishing cup, single-use
- Model / Ref / Catalog
- 1100073
- Primary DI / UDI-DI
- D0241100073
- FDA product code
- EHK, EJR
- GMDN term
- Dental polishing cup, single-use
- Device class
- Class I
- Regulation number
- 872.6290, 872.6030
- GUDID distribution status
- In Commercial Distribution