TELIO CS INLAY & TELIO CS ONLAY


Device Classification Name

crown and bridge, temporary, resin

510(k) Number K103379
Device Name TELIO CS INLAY & TELIO CS ONLAY
Applicant
IVOCLAR VIVADENT, INC.
175 pineview dr.
amherst, 
NY 
14228

Applicant Contact donna m hartnett
Correspondent
IVOCLAR VIVADENT, INC.
175 pineview dr.
amherst, 
NY 
14228

Correspodent Contact donna m hartnett
Regulation Number 872.3770
Classification Product Code
EBG  
Date Received 11/17/2010
Decision Date 02/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No