BEAUTIFIL OPAQUER


Device Classification Name

material, tooth shade, resin

510(k) Number K080068
Device Name BEAUTIFIL OPAQUER
Applicant
SHOFU DENTAL CORP.
1225 stone dr.
san marcos, 
CA 
92078

Applicant Contact david p morais
Correspondent
SHOFU DENTAL CORP.
1225 stone dr.
san marcos, 
CA 
92078

Correspodent Contact david p morais
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 01/10/2008
Decision Date 02/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No