HERO I DENTAL IMPLANT SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K121098
Device Name HERO I DENTAL IMPLANT SYSTEM
Applicant
KJ MEDITECH CO., LTD
951 starbuck st.
unit j
fullerton, 
CA 
92833

Applicant Contact priscilla chung
Correspondent
KJ MEDITECH CO., LTD
951 starbuck st.
unit j
fullerton, 
CA 
92833

Correspodent Contact priscilla chung
Regulation Number 872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received 04/11/2012
Decision Date 01/17/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No