Clearance Summary
820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS received FDA 510(k) clearance under submission number K851714, 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 1985-06-11.
- Submission: K851714
- Applicant / Sponsor: Artiberia
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1985-06-11
Classification & Regulation
This clearance is catalogued under FDA product code EMM and 21 CFR 872.4565, within the Dental review panel as a Class I device.