Ketac-Cem Maxicap
by Espe GmbH (Us) 510(k)
Active
510(k) K897188
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK897188 | Date27 Mar 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Overview
AI-generated summary, 6 Oct 2026
Ketac-Cem Maxicap is a dental cement used in dental procedures. It is classified as a dental cement under regulation 872.3275.
This device is supplied by Espe GmbH and received FDA 510(k) clearance on March 27, 1990. It is categorized as a Class II medical device.