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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 K991901
Device Name BIO-97
Applicant
Jeneric/Pentron, Inc.
53 N. Plains Industrial Rd.
P.O. Box 724
Wallingford,  CT  06492 -0724
Applicant Contact MURRAY G GAMBERG
Correspondent
Jeneric/Pentron, Inc.
53 N. Plains Industrial Rd.
P.O. Box 724
Wallingford,  CT  06492 -0724
Correspondent Contact MURRAY G GAMBERG
Regulation Number872.3060
Classification Product Code
EJT  
Date Received06/04/1999
Decision Date 09/07/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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