4 SEASONS


Device Classification Name

material, tooth shade, resin

510(k) Number K024094
Device Name 4 SEASONS
Original Applicant
IVOCLAR VIVADENT, INC.
175 pineview dr.
amherst, 
NY 
14228

Original Contact donna marie hartnett
Regulation Number 872.3690
Classification Product Code
EBF  
Date Received 12/11/2002
Decision Date 02/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No