GRANDIO CORE DUAL CURE


Device Classification Name

material, tooth shade, resin

510(k) Number K112447
Device Name GRANDIO CORE DUAL CURE
Applicant
VOCO GMBH
anton-flettner-strasse 1-3
cuxhaven, 

DE

d-27472

Applicant Contact t. gerkensmeier
Correspondent
VOCO GMBH
anton-flettner-strasse 1-3
cuxhaven, 

DE

d-27472

Correspodent Contact t. gerkensmeier
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 08/25/2011
Decision Date 11/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No