DENTIS DENTAL IMPLANT SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K073486
Device Name DENTIS DENTAL IMPLANT SYSTEM
Applicant
DENTIS CO. LTD.
13340 e firestone blvd
suite j
santa fe springs, 
CA 
90670

Applicant Contact chang dae kyu
Correspondent
DENTIS CO. LTD.
13340 e firestone blvd
suite j
santa fe springs, 
CA 
90670

Correspodent Contact chang dae kyu
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 12/12/2007
Decision Date 04/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No