Clearance Summary
CERADRILL received FDA 510(k) clearance under submission number K071352, sponsored by Gebr. Brasseler GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2007-06-29.
- Submission: K071352
- Applicant / Sponsor: Gebr. Brasseler GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3240
- Decision date: 2007-06-29
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.