510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K911937Substantially Equivalent

Osteomed Ib Drill

Osteomed, Glendale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911937 is the FDA 510(k) clearance record for OSTEOMED IB DRILL, a class I device, cleared for Osteomed Corp. on under FDA product code EFB (Handpiece, Air-Powered, Dental). FDA records list 73 510(k) clearances for Osteomed Corp., from to . As of , FDA records show no recalls naming K911937.

Clearance record

Decision date
Received
(40 days to decision)
Product code
EFB Handpiece, Air-Powered, Dental
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Osteomed Corp. 6062 San Fernando Rd., Glendale CA
510(k) summary
Statement
Third party review
No

Clearances, product code EFB

Trailing 12 months
4 clearances under product code EFB in the twelve months to November 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EFB, trailing twelve months
MonthClearances
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20261
November 20260