GRANDIO SO FLOW


Device Classification Name

material, tooth shade, resin

510(k) Number K103580
Device Name GRANDIO SO FLOW
Applicant
VOCO GMBH
anton-flettner-strasse 1-3
cuxhaven, 

DE

d-27472

Applicant Contact manfred thomas plaumann
Correspondent
VOCO GMBH
anton-flettner-strasse 1-3
cuxhaven, 

DE

d-27472

Correspodent Contact manfred thomas plaumann
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 12/06/2010
Decision Date 01/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No