Clearance Summary
QUICK-TIP (DENTAL OPERATORY UNIT) received FDA 510(k) clearance under submission number K891006, sponsored by Bernard S Esrock. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-05-24.
- Submission: K891006
- Applicant / Sponsor: Bernard S Esrock
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1989-05-24
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.