SLIM ONEBODY SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K111162
Device Name SLIM ONEBODY SYSTEM
Applicant
DENTIUM CO., LTD.
6761 katella avenue
cypress, 
CA 
90630

Applicant Contact eunkyung son
Correspondent
DENTIUM CO., LTD.
6761 katella avenue
cypress, 
CA 
90630

Correspodent Contact eunkyung son
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 04/25/2011
Decision Date 01/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No