UNIVERSAL CERAMIC SOLDER


Device Classification Name

alloy, gold-based noble metal

510(k) Number K022969
Device Name UNIVERSAL CERAMIC SOLDER
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 09/06/2002
Decision Date 10/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No