IROOT SP


Device Classification Name

resin, root canal filling

510(k) Number K080917
Device Name IROOT SP
Applicant
INNOVATIVE BIOCERAMIX INC.
1628 west 75th ave.
vancouver, bc, 

CA

v6p 6g2

Applicant Contact quanzu yang
Regulation Number 872.3820
Classification Product Code
KIF  
Date Received 04/01/2008
Decision Date 04/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No