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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 K061658
Device Name SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L
Applicant
Dentall Corp.
3 Faraday #B
Irvine,  CA  92618
Applicant Contact EDWIN FIRST
Correspondent
Dentall Corp.
3 Faraday #B
Irvine,  CA  92618
Correspondent Contact EDWIN FIRST
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received06/13/2006
Decision Date 09/18/2006
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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