SCANORA 3D


Device Classification Name

system,x-ray,extraoral source,digital

510(k) Number K073350
Device Name SCANORA 3D
Applicant
SOREDEX PALODEX GROUP OY
nahkelantie 160
tuusula, 

FI

fin-04300

Applicant Contact jouni onnela
Regulation Number 872.1800
Classification Product Code
MUH  
Subsequent Product Code
JAK  
Date Received 11/29/2007
Decision Date 12/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No