WELL-PEX


Device Classification Name

resin, root canal filling

510(k) Number K080266
Device Name WELL-PEX
Applicant
VERICOM CO., LTD.
#606,5th dongyoung venturestel
199-32, anyang 7-dong,manan-gu
anyang-si, gyeonggi-do, 

KR

430-817

Applicant Contact myung-hwan oh
Regulation Number 872.3820
Classification Product Code
KIF  
Date Received 02/01/2008
Decision Date 02/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No