CERVITEC PLUS


Device Classification Name

varnish, cavity

510(k) Number K072338
Device Name CERVITEC PLUS
Applicant
IVOCLAR VIVADENT, INC.
175 pineview dr.
amherst, 
NY 
14228

Applicant Contact donna marie hartnett
Correspondent
IVOCLAR VIVADENT, INC.
175 pineview dr.
amherst, 
NY 
14228

Correspodent Contact donna marie hartnett
Regulation Number 872.3260
Classification Product Code
LBH  
Date Received 08/20/2007
Decision Date 09/21/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No