MI Paste Plus™ 422886
MI Paste Plus™ 422886 is a Class I device made by Gc America Inc., cleared under FDA 510(k) K070854 on 12 Apr 2007 and listed in FDA GUDID since 13 Jul 2022 (UDI-DI 10386040008617), 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 | Number10386040008617 | Date13 Jul 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK070854 | Date12 Apr 2007 | StatusActive |
Official records
- AccessGUDID record 10386040008617
- FDA 510(k) database K070854
Across registries
- FDA 510(k) K070854 decided 12 Apr 2007 Active
- FDA GUDID UDI-DI 10386040008617 listed 13 Jul 2022 Listed
Timeline
- Cleared FDA 510(k) K070854
- Listed FDA GUDID 10386040008617
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MI Paste Plus™
- Generic name
- Dental coating, tooth-desensitizing, professional
- Model / Ref / Catalog
- 422886
- Primary DI / UDI-DI
- 10386040008617
- 510(k) Number
- FDA product code
- EJR
- GMDN term
- Dental coating, tooth-desensitizing, professional
- Device class
- Class I
- Regulation number
- 872.6030
- GUDID distribution status
- In Commercial Distribution
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