VOCO PROFLUORID VARNISH


Device Classification Name

varnish, cavity

510(k) Number K080814
Device Name VOCO PROFLUORID VARNISH
Applicant
VOCO GMBH
anton-flettner-strasse 1-3
cuxhaven, 

DE

d-27472

Applicant Contact m.th plaumann
Correspondent
VOCO GMBH
anton-flettner-strasse 1-3
cuxhaven, 

DE

d-27472

Correspodent Contact m.th plaumann
Regulation Number 872.3260
Classification Product Code
LBH  
Date Received 03/24/2008
Decision Date 07/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No