Clearance Summary
POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001 received FDA 510(k) clearance under submission number K983029, sponsored by Tpc Advanced Technology, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1999-01-29.
- Submission: K983029
- Applicant / Sponsor: Tpc Advanced Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4850
- Decision date: 1999-01-29
Classification & Regulation
This clearance is catalogued under FDA product code ELC and 21 CFR 872.4850, within the Dental review panel as a Class II device.