X-TRA BASE


Device Classification Name

material, tooth shade, resin

510(k) Number K112374
Device Name X-TRA BASE
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 08/17/2011
Decision Date 10/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No