The following data is part of a premarket notification filed by S.s. White Burs, Inc. with the FDA for Smartburs.
| Device ID | K080687 |
| 510k Number | K080687 |
| Device Name: | SMARTBURS |
| Classification | Bur, Dental |
| Applicant | S.S. WHITE BURS, INC. 1145 TOWBIN AVE. Lakewood, NJ 08701 |
| Contact | Derek Gladden |
| Correspondent | Derek Gladden S.S. WHITE BURS, INC. 1145 TOWBIN AVE. Lakewood, NJ 08701 |
| Product Code | EJL |
| CFR Regulation Number | 872.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-11 |
| Decision Date | 2008-06-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SMARTBURS 78339012 3088383 Live/Registered |
S.S. White Burs, Inc. 2003-12-10 |