FOUNDATION DENTAL RESIN


Device Classification Name

resin, denture, relining, repairing, rebasing

510(k) Number K111709
Device Name FOUNDATION DENTAL RESIN
Applicant
UNIX-JAPAN CO., LTD.
10920 wilshire blvd
suite 150
los angeles, 
CA 
90024

Applicant Contact toshiko boyd
Correspondent
UNIX-JAPAN CO., LTD.
10920 wilshire blvd
suite 150
los angeles, 
CA 
90024

Correspodent Contact toshiko boyd
Regulation Number 872.3760
Classification Product Code
EBI  
Date Received 06/20/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No