Cmw Cement Pressurisation System
by Dentsply Intl. 510(k)
Active
510(k) K897134
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK897134 | Date2 Mar 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 11 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KIH
- Device Class
- Class I
- Regulation
- 21 CFR Part 888.4200
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent