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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K013584
Device Name EXCITE SELF ETCH
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
Correspondent Contact DONNA M HARTNETT
Regulation Number872.3200
Classification Product Code
KLE  
Date Received10/30/2001
Decision Date 01/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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