BIOUNIVERSAL PDF


Device Classification Name

alloy, gold-based noble metal

510(k) Number K011022
Device Name BIOUNIVERSAL PDF
Original Applicant
IVOCLAR NORTH AMERICA, INC.
175 pineview dr.
amherst, 
NY 
14228

Original Contact andy gulati
Regulation Number 872.3060
Classification Product Code
EJT  
Date Received 04/04/2001
Decision Date 05/02/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No