CONCEPT HP ADD-ON; CONCEPT HP ENAMEL

Device Classification Name

material, tooth shade, resin

510(k) Number K033773
Device Name CONCEPT HP ADD-ON; CONCEPT HP ENAMEL
Applicant
IVOCLAR VIVADENT AG
175 pineview dr.
amherst, 
NY 
14228

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

Correspodent Contact donna marie hartnett
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 12/03/2003
Decision Date 01/15/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No