Osteomed Ib Drill
510(k) K911937
Osteomed Ib Drill is a medical device (FDA Class I; FDA product code EFB, Handpiece, Air-Powered, Dental) made by Osteomed Corp., cleared under FDA 510(k) K911937 on 10 Jun 1991, 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 | NumberK911937 | Date10 Jun 1991 | StatusActive |
Official records
- FDA 510(k) database K911937
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EFB
- Device class
- Class I
- Regulation
- 21 CFR Part 872.4200
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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