W-5


Device Classification Name

alloy, gold-based noble metal

510(k) Number K022811
Device Name W-5
Original Applicant
IVOCLAR VIVADENT, INC.
175 pineview dr.
amherst, 
NY 
14228

Original Contact anderjeet gulati
Regulation Number 872.3060
Classification Product Code
EJT  
Date Received 08/23/2002
Decision Date 10/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No