I-ROOT 100


Device Classification Name

locator, root apex

510(k) Number K112508
Device Name I-ROOT 100
Applicant
S-DENTI CO., LTD.
valley 6,481-4
gasan-dong geumcheon-gu
tae kye nam, 

KR

153-803

Applicant Contact tae k nam
Correspondent
S-DENTI CO., LTD.
valley 6,481-4
gasan-dong geumcheon-gu
tae kye nam, 

KR

153-803

Correspodent Contact tae k nam
Classification Product Code
LQY  
Date Received 08/30/2011
Decision Date 06/19/2012
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No