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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 K010044
Device Name COSMIC
Applicant
Jeneric/Pentron, Inc.
53 N. Plains
Industrial Rd.
Wallingford,  CT  06492 -0724
Applicant Contact ANNMARIE TENERO
Correspondent
Jeneric/Pentron, Inc.
53 N. Plains
Industrial Rd.
Wallingford,  CT  06492 -0724
Correspondent Contact ANNMARIE TENERO
Regulation Number872.3060
Classification Product Code
EJT  
Date Received01/05/2001
Decision Date 02/09/2001
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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