Kooliner™ 345091
Kooliner™ 345091 is a Class II device made by Gc America Inc., listed in FDA GUDID since 7 Jul 2022 (UDI-DI 10386040003759), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10386040003759 | Date7 Jul 2022 | StatusListed |
Official records
- AccessGUDID record 10386040003759
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Kooliner™
- Generic name
- Denture reliner, hard
- Model / Ref / Catalog
- 345091
- Primary DI / UDI-DI
- 10386040003759
- FDA product code
- EBI
- GMDN term
- Denture reliner, hard
- Device class
- Class II
- Regulation number
- 872.3760
- GUDID distribution status
- In Commercial Distribution
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