Clearance Summary
PROSTHODONTIC SCREWDRIVER , MODEL IA-400 received FDA 510(k) clearance under submission number K100600, sponsored by W&H Dentalwerk Buermoos 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 2010-07-09.
- Submission: K100600
- Applicant / Sponsor: W&H Dentalwerk Buermoos GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2010-07-09
Classification & Regulation
This clearance is catalogued under FDA product code EKX and 21 CFR 872.4200, within the Dental review panel as a Class I device.