SMARTBURS


Device Classification Name

bur, dental

510(k) Number K080687
Device Name SMARTBURS
Applicant
S.S. WHITE BURS, INC.
1145 towbin ave.
lakewood, 
NJ 
08701

Applicant Contact derek gladden
Correspondent
S.S. WHITE BURS, INC.
1145 towbin ave.
lakewood, 
NJ 
08701

Correspodent Contact derek gladden
Regulation Number 872.3240
Classification Product Code
EJL  
Date Received 03/11/2008
Decision Date 06/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No