Clearance Summary
DENTAL ROTARY CARBIDE BURS 76EJL received FDA 510(k) clearance under submission number K780641, sponsored by Teledyne Densco. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1978-04-21.
- Submission: K780641
- Applicant / Sponsor: Teledyne Densco
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3240
- Decision date: 1978-04-21
Classification & Regulation
This clearance is catalogued under FDA product code EJL and 21 CFR 872.3240, within the Dental review panel as a Class I device.