Pro-Kleen 854542008037
Pro-Kleen 854542008037 (MAK-1910) is a Class I device made by Anodia Systems, cleared under FDA 510(k) K023815 on 19 Jun 2003 and listed in FDA GUDID since 19 Aug 2023 (UDI-DI 00854542008037), 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 | Number00854542008037 | Date19 Aug 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK023815 | Date19 Jun 2003 | StatusActive |
Official records
- AccessGUDID record 00854542008037
- FDA 510(k) database K023815
Across registries
- FDA 510(k) K023815 decided 19 Jun 2003 Active
- FDA GUDID UDI-DI 00854542008037 listed 19 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K023815
- Listed FDA GUDID 00854542008037
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pro-Kleen
- Generic name
- Dental delivery system
- Model / Ref / Catalog
- 854542008037, MAK-1910
- Primary DI / UDI-DI
- 00854542008037
- 510(k) Number
- FDA product code
- EIA
- GMDN term
- Dental delivery system
- Device class
- Class I
- Regulation number
- 872.6640
- GUDID distribution status
- In Commercial Distribution
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