DENTOCORE/DENTOCORE BODY


Device Classification Name

material, tooth shade, resin

510(k) Number K121769
Device Name DENTOCORE/DENTOCORE BODY
Applicant
ITENA CLINICAL
500 boul cartier west
laval, 

CA

h7v 5b7

Applicant Contact louis- paul marin
Correspondent
ITENA CLINICAL
500 boul cartier west
laval, 

CA

h7v 5b7

Correspodent Contact louis- paul marin
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 06/15/2012
Decision Date 03/05/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No