Clearance Summary
CUTTING FLUID SYSTEM FOR DENTAL HIGH SPEED DRILLS received FDA 510(k) clearance under submission number K882491, sponsored by Steri-Sol, 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 1988-08-26.
- Submission: K882491
- Applicant / Sponsor: Steri-Sol, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1988-08-26
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.