BIO UNIVERSAL


Device Classification Name

alloy, gold-based noble metal

510(k) Number K030436
Device Name BIO UNIVERSAL
Applicant
IVOCLAR VIVADENT, INC.
175 pineview dr.
amherst, 
NY 
14228

Applicant Contact anderjeet gulati
Correspondent
IVOCLAR VIVADENT, INC.
175 pineview dr.
amherst, 
NY 
14228

Correspodent Contact anderjeet gulati
Regulation Number 872.3060
Classification Product Code
EJT  
Date Received 02/10/2003
Decision Date 04/15/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No