ORTHOPHOS XG 3D / CEPH


Device Classification Name

x-ray, tomography, computed, dental

510(k) Number K103711
Device Name ORTHOPHOS XG 3D / CEPH
Applicant
SIRONA DENTAL SYSTEMS GMBH
fabrikstrasse 31
bensheim, 

DE

64625

Applicant Contact fritz kolle
Correspondent
SIRONA DENTAL SYSTEMS GMBH
fabrikstrasse 31
bensheim, 

DE

64625

Correspodent Contact fritz kolle
Regulation Number 892.1750
Classification Product Code
OAS  
Date Received 12/20/2010
Decision Date 03/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No