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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K012946
Device Name SUNLITELED MODEL #2810
Applicant
Kinetic Instruments, Inc.
17 Berkshire Blvd.
Bethel,  CT  06801
Applicant Contact WILLIAM J BECKER
Correspondent
Kinetic Instruments, Inc.
17 Berkshire Blvd.
Bethel,  CT  06801
Correspondent Contact WILLIAM J BECKER
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received09/04/2001
Decision Date 10/02/2001
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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