Clearance Summary
Angled Screwdriver MED (M-SD090) received FDA 510(k) clearance under submission number K253655, sponsored by W&H Dentalwerk Bürmoos GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2026-07-31.
- Submission: K253655
- Applicant / Sponsor: W&H Dentalwerk Bürmoos GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4120
- Decision date: 2026-07-31
Classification & Regulation
This clearance is catalogued under FDA product code DZI and 21 CFR 872.4120, within the Dental review panel as a Class II device.