PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL


Device Classification Name

material, tooth shade, resin

510(k) Number K022675
Device Name PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL
Original Applicant
PRIME DENTAL MANUFACTURING, INC.
3735 west belmont ave.
chicago, 
IL 
60618

Original Contact rolando marasigan
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 08/12/2002
Decision Date 11/07/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No