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 |