NEXCOMP AND META ETCHANT


Device Classification Name

material, tooth shade, resin

510(k) Number K080305
Device Name NEXCOMP AND META ETCHANT
Applicant
META BIOMED CO., LTD.
414-12 mo choong dong
cheong ju
cheung city, chung buk, 

KR

441-12

Applicant Contact tae-hoon kim
Correspondent
META BIOMED CO., LTD.
414-12 mo choong dong
cheong ju
cheung city, chung buk, 

KR

441-12

Correspodent Contact tae-hoon kim
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 02/05/2008
Decision Date 04/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No