510(k) K071352

CERADRILL by Gebr. Brasseler GmbH & Co. KG — Product Code EJL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2007
Date Received
May 15, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Bur, Dental
Device Class
Class I
Regulation Number
872.3240
Review Panel
DE
Submission Type