SIRONA DENTAL CAD/CAM SYSTEM


Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K111421
Device Name SIRONA DENTAL CAD/CAM SYSTEM
Applicant
SIRONA DENTAL SYSTEMS GMBH
fabrikstrasse 31
bensheim, 

DE

d-64625

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

DE

d-64625

Correspodent Contact fritz kolle
Regulation Number 872.3630
Classification Product Code
NHA  
Date Received 05/20/2011
Decision Date 02/17/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No