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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Amalgam
510(k) Number K951865
Device Name ULTRA SPHERICAL AMALGAM ALLOY
Applicant
Goldsmith & Revere, Inc.
242 S. Dean St.
Englewood,  NJ  07631
Applicant Contact D. T WOLF
Correspondent
Goldsmith & Revere, Inc.
242 S. Dean St.
Englewood,  NJ  07631
Correspondent Contact D. T WOLF
Regulation Number872.3070
Classification Product Code
EJJ  
Date Received04/21/1995
Decision Date 05/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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