Clearance Summary
SANI-PIKS DENTAL HAND INSTRUMENT received FDA 510(k) clearance under submission number K895985, sponsored by Bison-Lee Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1990-01-10.
- Submission: K895985
- Applicant / Sponsor: Bison-Lee Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1990-01-10
Classification & Regulation
This clearance is catalogued under FDA product code EKJ and 21 CFR 872.4565, within the Dental review panel as a Class I device.