ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)


Device Classification Name

resin, root canal filling

510(k) Number K112078
Device Name ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
Applicant
MARUCHI
951 starbuck st. unit j
fullerton, 
CA 
92833

Applicant Contact priscilla chung
Correspondent
MARUCHI
951 starbuck st. unit j
fullerton, 
CA 
92833

Correspodent Contact priscilla chung
Regulation Number 872.3820
Classification Product Code
KIF  
Date Received 07/21/2011
Decision Date 03/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No