Clearance Summary
TITANE SL DENTAL BURR received FDA 510(k) clearance under submission number K872471, sponsored by Titane SL 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 1987-09-11.
- Submission: K872471
- Applicant / Sponsor: Titane SL Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5410
- Decision date: 1987-09-11
Classification & Regulation
This clearance is catalogued under FDA product code ECM and 21 CFR 872.5410, within the Dental review panel as a Class I device.