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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 K993223
Device Name RAPICURE 200 (CURING AND WHITENING LIGHT)
Applicant
Mediphotonix, LC
484 H St.
Salt Lake City,  UT  84103
Applicant Contact ROBERT MCCLANE
Correspondent
Mediphotonix, LC
484 H St.
Salt Lake City,  UT  84103
Correspondent Contact ROBERT MCCLANE
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received09/27/1999
Decision Date 11/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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