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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 K932243
Device Name GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO
Original Applicant
PRECIOUS CHEMICALS U.S.A., INC.
2151 long ridge rd.
stamford,  CT  06903
Original Contact eugene lieberstein
Regulation Number872.3060
Classification Product Code
EJT  
Date Received05/07/1993
Decision Date 04/28/1994
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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