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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K864306
Device Name VERINOR ALLOY
Applicant
Degussa Dental, Inc.
21-25 44th Ave.
Long Island,  NY  11101
Applicant Contact ROTHAUT, PH.D.
Correspondent
Degussa Dental, Inc.
21-25 44th Ave.
Long Island,  NY  11101
Correspondent Contact ROTHAUT, PH.D.
Regulation Number872.3060
Classification Product Code
EJT  
Date Received11/03/1986
Decision Date 11/26/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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