Angled Screwdriver MED (M-SD090)— 510(k) K253655

Name: FDA 510(k) clearance K253655
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Substantially Equivalent

W&H Dentalwerk Bürmoos GmbH

FDA 510(k) clearance K253655 for Angled Screwdriver MED (M-SD090), Substantially Equivalent on 2026-07-31. Applicant: W&H Dentalwerk Bürmoos GmbH. Device class: 2.

Summary

W&H Dentalwerk Bürmoos's Angled Screwdriver MED (M-SD090) is filed under DZI, powered bone drills. The device name describes a screwdriver, which the code name doesn't mention, and the record doesn't explain the fit.

Class II, 21 CFR 872.4120. Dental is both the classification panel and the review panel. It was a Traditional 510(k).

W&H filed from Buermoos, Austria. Review took 253 calendar days (November 20, 2025 to July 31, 2026).

Clearance details

Applicant: W&H Dentalwerk Bürmoos GmbH
Product code: Product code DZI
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2025-11-20
Decision date: 2026-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buermoos, AT

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.