SIMPLELINE II ABUTMENT SYSTEM


Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K112045
Device Name SIMPLELINE II ABUTMENT SYSTEM
Applicant
DENTIUM CO., LTD.
27-5 leui-dong, yeongtong-gu
suwon-si, gyeonggi-do, 

KR

442-270

Applicant Contact jonghyun choi
Correspondent
DENTIUM CO., LTD.
27-5 leui-dong, yeongtong-gu
suwon-si, gyeonggi-do, 

KR

442-270

Correspodent Contact jonghyun choi
Regulation Number 872.3630
Classification Product Code
NHA  
Date Received 07/18/2011
Decision Date 01/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No