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 |