EVADYNE TEMPORARY CROWN AND BRIDGE RESIN


Device Classification Name

crown and bridge, temporary, resin

510(k) Number K111666
Device Name EVADYNE TEMPORARY CROWN AND BRIDGE RESIN
Applicant
NEO DENTAL CHEMICAL PRODUCTS CO., LTD.
611 west 5th street
austin, 
TX 
78701

Applicant Contact robert seiple
Correspondent
NEO DENTAL CHEMICAL PRODUCTS CO., LTD.
611 west 5th street
austin, 
TX 
78701

Correspodent Contact robert seiple
Regulation Number 872.3770
Classification Product Code
EBG  
Date Received 06/14/2011
Decision Date 09/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No