Clearance Summary
ANEST-EZE DENTAL DRILL RA#2 received FDA 510(k) clearance under submission number K896149, sponsored by Signature One Products, 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 1990-01-19.
- Submission: K896149
- Applicant / Sponsor: Signature One Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4130
- Decision date: 1990-01-19
Classification & Regulation
This clearance is catalogued under FDA product code DZA and 21 CFR 872.4130, within the Dental review panel as a Class I device.