Clearance Summary
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM received FDA 510(k) clearance under submission number K100647, sponsored by A-Dec, 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 2010-07-09.
- Submission: K100647
- Applicant / Sponsor: A-Dec, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4850
- Decision date: 2010-07-09
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.