Ketac Universal Aplicap
510(k) K153174
Ketac Universal Aplicap is a Class II device made by 3M Deutschland GmbH, cleared under FDA 510(k) K153174 on 13 Apr 2016, 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 | NumberK153174 | Date13 Apr 2016 | StatusActive |
Official records
- FDA 510(k) database K153174
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EMA
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3275
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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