Clearance Summary
1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS received FDA 510(k) clearance under submission number K851722, sponsored by Artiberia. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1985-07-02.
- Submission: K851722
- Applicant / Sponsor: Artiberia
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1985-07-02
Classification & Regulation
This clearance is catalogued under FDA product code EKC and 21 CFR 872.4565, within the Dental review panel as a Class I device.