KJ SUBMERGED SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K103810
Device Name KJ SUBMERGED 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  
Date Received 12/29/2010
Decision Date 09/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No