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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 K023501
Device Name GOLD CORE 35
Applicant
Pentron Laboratory Technologies
53 N. Plains
Industrial Rd.
Wallingford,  CT  06492
Applicant Contact GREG JIMMIE
Correspondent
Pentron Laboratory Technologies
53 N. Plains
Industrial Rd.
Wallingford,  CT  06492
Correspondent Contact GREG JIMMIE
Regulation Number872.3060
Classification Product Code
EJT  
Date Received10/18/2002
Decision Date 12/18/2002
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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