IVOBASE HYBRID, IVOBASE HIGH IMPACT


Device Classification Name

resin, denture, relining, repairing, rebasing

510(k) Number K103391
Device Name IVOBASE HYBRID, IVOBASE HIGH IMPACT
Applicant
IVOCLAR VIVADENT, INC.
175 pineview dr.
amherst, 
NY 
14228

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

Correspodent Contact donna hartnett
Regulation Number 872.3760
Classification Product Code
EBI  
Date Received 11/19/2010
Decision Date 02/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No