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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 K002991
Device Name ZAP DUAL CURING LIGHT
Applicant
Soft-Core Texas, Inc.
5424 Rufe Snow Dr., #102
North Richland Hills,  TX  76180
Applicant Contact ROY MARTIN
Correspondent
Soft-Core Texas, Inc.
5424 Rufe Snow Dr., #102
North Richland Hills,  TX  76180
Correspondent Contact ROY MARTIN
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received09/25/2000
Decision Date 11/28/2000
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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