510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971692Substantially Equivalent

Osteopower System and Accessories

Osteomed, Irving TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971692 is the FDA 510(k) clearance record for OSTEOPOWER SYSTEM AND ACCESSORIES, a class II device, cleared for Osteomed Corp. on under FDA product code KMW (Handpiece, Rotary Bone Cutting). FDA records list 73 510(k) clearances for Osteomed Corp., from to . As of , FDA records show one recall naming K971692.

Clearance record

Decision date
Received
(51 days to decision)
Product code
KMW Handpiece, Rotary Bone Cutting
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Osteomed Corp. 3150 Premier Dr., Irving TX
510(k) summary
Statement
Third party review
No

Clearances, product code KMW

Trailing 12 months

FDA records hold no clearances under product code KMW in the trailing twelve months.

FDA records show no clearances under product code KMW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260