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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Operating, Dental
510(k) Number K003995
Device Name SPECULITE/ORALLITE
Applicant
Trylon Corp.
970 W. 190th St., Suite 850
Torrance,  CA  90502
Applicant Contact MARTIN LONKY
Correspondent
Trylon Corp.
970 W. 190th St., Suite 850
Torrance,  CA  90502
Correspondent Contact MARTIN LONKY
Regulation Number872.4630
Classification Product Code
EAZ  
Date Received12/26/2000
Decision Date 03/16/2001
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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