Clearance Summary
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) received FDA 510(k) clearance under submission number K002469, 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 2001-02-07.
- Submission: K002469
- 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: 2001-02-07
Classification & Regulation
This clearance is catalogued under FDA product code EBW and 21 CFR 872.4200, within the Dental review panel as a Class I device.