SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER


Device Classification Name

denture, plastic, teeth

510(k) Number K023035
Device Name SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
Original Applicant
IVOCLAR VIVADENT, INC.
175 pineview dr.
amherst, 
NY 
14228

Original Contact donna marie hartnett
Regulation Number 872.3590
Classification Product Code
ELM  
Date Received 09/12/2002
Decision Date 12/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No