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Surgical Handpieces, Mikro Saw Handpieces

by W&H Dentalwerk Buermoos GmbH

510(k) K080939

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080939 Date29 Jul 2008ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1168-2024 FDA Class II initiated 16 Jan 2024

    1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the handpiece

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KMW
Device Class
Class II
Regulation
21 CFR Part 872.4120
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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