The following data is part of a premarket notification filed by Gebr. Brasseler Gmbh & Co. Kg with the FDA for Ceradrill.
Device ID | K071352 |
510k Number | K071352 |
Device Name: | CERADRILL |
Classification | Bur, Dental |
Applicant | GEBR. BRASSELER GMBH & CO. KG TROPHAGENER WEG 25 Lemgo, DE D-32657 |
Contact | Olaf Brand |
Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
Product Code | EJL |
CFR Regulation Number | 872.3240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-05-15 |
Decision Date | 2007-06-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
E226035212A11 | K071352 | 000 |
E226035211A11 | K071352 | 000 |
E226034900A11 | K071352 | 000 |
E226034899A11 | K071352 | 000 |
E226033794A11 | K071352 | 000 |
E226033793A11 | K071352 | 000 |
E226033792A11 | K071352 | 000 |
E226033795A11 | K071352 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CERADRILL 78919012 3459662 Live/Registered |
Gebr. Brasseler GmbH & Co. KG 2006-06-28 |