Kooliner II
510(k) K935261
Kooliner II is a Class II device made by Gc America Inc., cleared under FDA 510(k) K935261 on 26 Jan 1994, 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 | FDA 510(k)SESE | NumberK935261 | Date26 Jan 1994 | StatusActive |
Official records
- FDA 510(k) database K935261
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBI
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3760
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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