Clearance Summary
SYNEA-HS HIGH SPEED-HANDPIECE received FDA 510(k) clearance under submission number K992011, 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 1999-09-10.
- Submission: K992011
- Applicant / Sponsor: A-Dec, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1999-09-10
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.