IROOT 100 MINI


Device Classification Name

locator, root apex

510(k) Number K112153
Device Name IROOT 100 MINI
Applicant
S-DENTI CO., LTD.
300 atwood
pittsburgh, 
PA 
15213

Applicant Contact peter chung
Correspondent
S-DENTI CO., LTD.
300 atwood
pittsburgh, 
PA 
15213

Correspodent Contact peter chung
Classification Product Code
LQY  
Date Received 07/07/2011
Decision Date 04/26/2012
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No