510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K080939Substantially Equivalent

Surgical Handpieces, Mikro Saw Handpieces

W & H DentalWerk Buermoos GmbH, Buermoos, AT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080939 is the FDA 510(k) clearance record for SURGICAL HANDPIECES, MIKRO SAW HANDPIECES, a class II device, cleared for W&H Dentalwerk Buermoos GmbH on under FDA product code KMW (Handpiece, Rotary Bone Cutting). FDA records list 18 510(k) clearances for W&H Dentalwerk Buermoos GmbH, from to . As of , FDA records show one recall naming K080939.

Clearance record

Decision date
Received
(117 days to decision)
Product code
KMW Handpiece, Rotary Bone Cutting
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
W&H Dentalwerk Buermoos GmbH 53 Ignaz-Glaser-Strasse, Buermoos, AT
510(k) summary
Summary PDF
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