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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 K954061
Device Name POLY-LITE MODEL 1000
Applicant
Pro-Den Systems, Inc.
13915 NW 3rd Ct.
Vancouver,  WA  98685
Applicant Contact CADE ADAMS
Correspondent
Pro-Den Systems, Inc.
13915 NW 3rd Ct.
Vancouver,  WA  98685
Correspondent Contact CADE ADAMS
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received08/29/1995
Decision Date 09/21/1995
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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