PLANMECA PROONE


Device Classification Name

system,x-ray,extraoral source,digital

510(k) Number K072244
Device Name PLANMECA PROONE
Applicant
PLANMECA OY
asentajankatu 6
helsinki, 

FI

00880

Applicant Contact lars moring
Correspondent
PLANMECA OY
asentajankatu 6
helsinki, 

FI

00880

Correspodent Contact lars moring
Regulation Number 872.1800
Classification Product Code
MUH  
Date Received 08/13/2007
Decision Date 09/21/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No