JNE IMPLANT SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K072425
Device Name JNE IMPLANT SYSTEM
Applicant
GC AMERICA, INC.
1025 everett road, suite 100
lake forest, 
IL 
60045

Applicant Contact carl jenkins
Correspondent
GC AMERICA, INC.
1025 everett road, suite 100
lake forest, 
IL 
60045

Correspodent Contact carl jenkins
Regulation Number 872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received 08/29/2007
Decision Date 03/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No