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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
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