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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
Applicant
Precious Chemicals U.S.A., Inc.
2151 Long Ridge Rd.
Stamford,  CT  06903
Applicant Contact EUGENE LIEBERSTEIN
Correspondent
Precious Chemicals U.S.A., Inc.
2151 Long Ridge Rd.
Stamford,  CT  06903
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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