RESICEM


Device Classification Name

cement, dental

510(k) Number K080517
Device Name RESICEM
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 872.3275
Classification Product Code
EMA  
Date Received 02/25/2008
Decision Date 06/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No