Clearance Summary
586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC received FDA 510(k) clearance under submission number K851710, 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: K851710
- 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 EMH and 21 CFR 872.4565, within the Dental review panel as a Class I device.