PLANMECA PROMAX 3D MID


Device Classification Name

system,x-ray,extraoral source,digital

510(k) Number K103689
Device Name PLANMECA PROMAX 3D MID
Applicant
PLANMECA OY
asentajankatu 6
helsinki, 

FI

fi-00880

Applicant Contact lars moring
Correspondent
PLANMECA OY
asentajankatu 6
helsinki, 

FI

fi-00880

Correspodent Contact lars moring
Regulation Number 872.1800
Classification Product Code
MUH  
Date Received 12/17/2010
Decision Date 03/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No