PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT


Device Classification Name

cement, dental

510(k) Number K112574
Device Name PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT
Applicant
PRIME DENTAL MANUFACTURING, INC.
4555 west addison street
chicago, 
IL 
60641

Applicant Contact javier alvarez
Correspondent
PRIME DENTAL MANUFACTURING, INC.
4555 west addison street
chicago, 
IL 
60641

Correspodent Contact javier alvarez
Regulation Number 872.3275
Classification Product Code
EMA  
Date Received 09/06/2011
Decision Date 01/23/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No