BEAUTISEALANT


Device Classification Name

sealant, pit and fissure, and conditioner

510(k) Number K111782
Device Name BEAUTISEALANT
Applicant
SHOFU DENTAL CORPORATION
1225 stone drive
san marcos, 
CA 
92078

Applicant Contact david p morais
Correspondent
SHOFU DENTAL CORPORATION
1225 stone drive
san marcos, 
CA 
92078

Correspodent Contact david p morais
Regulation Number 872.3765
Classification Product Code
EBC  
Date Received 06/24/2011
Decision Date 09/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No