ESCOM 100


Device Classification Name

material, tooth shade, resin

510(k) Number K110428
Device Name ESCOM 100
Applicant
SPIDENT CO., LTD.
korea industrial complex 722
kojan-dong, namdong-ku
incheon, 

KR

405-821

Applicant Contact je mo ahn
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 02/14/2011
Decision Date 02/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No