Mizzy Millennium 6010039
Mizzy Millennium 6010039 is a Class II device made by Keystone Industries, cleared under FDA 510(k) K983876 on 16 Dec 1998 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI H66860100391), 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 | NumberH66860100391 | Date15 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK983876 | Date16 Dec 1998 | StatusActive |
Official records
- FDA 510(k) database K983876
Across registries
- FDA 510(k) K983876 decided 16 Dec 1998 Active
- FDA GUDID UDI-DI H66860100391 listed 15 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K983876
- Listed FDA GUDID H66860100391
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mizzy Millennium
- Generic name
- Denture repair kit, professional
- Model / Ref / Catalog
- 6010039
- Primary DI / UDI-DI
- H66860100391
- 510(k) Number
- FDA product code
- EBI
- GMDN term
- Denture repair kit, professional
- Device class
- Class II
- Regulation number
- 872.3760
- GUDID distribution status
- In Commercial Distribution
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- VERSYO.DIRECT by Heraeus Kulzer, Inc.