Clearance Summary
POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 received FDA 510(k) clearance under submission number K051547, sponsored by Tpc Advanced Technology, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2005-07-14.
- Submission: K051547
- Applicant / Sponsor: Tpc Advanced Technology, Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4850
- Decision date: 2005-07-14
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.