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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Intraoral
510(k) Number K093453
Device Name MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
Applicant
Schick Technologies, Inc.
30-30 47th Ave.
Long Island City,  NY  11101
Applicant Contact HOWARD FIDEL
Correspondent
Schick Technologies, Inc.
30-30 47th Ave.
Long Island City,  NY  11101
Correspondent Contact HOWARD FIDEL
Regulation Number872.1810
Classification Product Code
EAP  
Subsequent Product Code
MQB  
Date Received11/05/2009
Decision Date 11/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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