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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K020206
Device Name INTRAORAL CAMERA ME-15
Applicant
Dent Corp. Research & Development
7-11 S. Broadway
White Plains,  NY  10601
Applicant Contact DAVID ABELDA
Correspondent
Dent Corp. Research & Development
7-11 S. Broadway
White Plains,  NY  10601
Correspondent Contact DAVID ABELDA
Regulation Number872.6640
Classification Product Code
EIA  
Date Received01/22/2002
Decision Date 04/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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