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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K823409
Device Name HELIOSIT-ORTHODONTIC
Applicant
Vivadent (Usa), Inc.
175 Pineview Dr.
Amherst,  NY  14228
Applicant Contact Donna Marie Hartnett
Correspondent
Vivadent (Usa), Inc.
175 Pineview Dr.
Amherst,  NY  14228
Correspondent Contact Donna Marie Hartnett
Regulation Number872.3750
Classification Product Code
DYH  
Date Received11/15/1982
Decision Date 01/21/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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