SIMPLANT ORTHO ; VISTADENT 3D


Device Classification Name

system, image processing, radiological

510(k) Number K081402
Device Name SIMPLANT ORTHO ; VISTADENT 3D
Applicant
MATERIALISE DENTAL NV
technologielaan 15
leuven, 

BE

3001

Applicant Contact carl van lierde
Correspondent
MATERIALISE DENTAL NV
technologielaan 15
leuven, 

BE

3001

Correspodent Contact carl van lierde
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/19/2008
Decision Date 07/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No