Premier 1040117
by Premier Dental Products Company
Premier 1040117 is a Class II device made by Premier Dental Products Company, cleared under FDA 510(k) K031463 on 18 Nov 2003 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI D6911040117), 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 | NumberD6911040117 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK031463 | Date18 Nov 2003 | StatusActive |
Official records
- FDA 510(k) database K031463
Across registries
- FDA 510(k) K031463 decided 18 Nov 2003 Active
- FDA GUDID UDI-DI D6911040117 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K031463
- Listed FDA GUDID D6911040117
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Premier
- Generic name
- Pelvic-organ-supporting pessary
- Model / reference
- 1040117
- Primary DI / UDI-DI
- D6911040117
- 510(k) Number
- FDA product code
- HHW
- GMDN term
- Pelvic-organ-supporting pessary
- Device class
- Class II
- Regulation number
- 884.3575
- GUDID distribution status
- In Commercial Distribution
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