CIMARA


Device Classification Name

material, tooth shade, resin

510(k) Number K110589
Device Name CIMARA
Applicant
VOCO GMBH
anton-flettner-strasse 1-3
cuxhaven, 

DE

27472

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

DE

27472

Correspodent Contact manfred t plaumann
Regulation Number 872.3690
Classification Product Code
EBF  
Subsequent Product Code
KLE  
Date Received 03/02/2011
Decision Date 05/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No