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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 K890568
Device Name ULTIMA LITE
Applicant
Deringer-Ney, Inc.
Ney Industrial Park
Bloomfield,  CT  06002
Applicant Contact JOHN M KUZMECH
Correspondent
Deringer-Ney, Inc.
Ney Industrial Park
Bloomfield,  CT  06002
Correspondent Contact JOHN M KUZMECH
Regulation Number872.3060
Classification Product Code
EJT  
Date Received02/06/1989
Decision Date 03/09/1989
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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