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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 K002620
Device Name SURESMILE SYSTEM
Applicant
Orametrix, Inc.
12740 Hillcrest Rd., Suite 100
Dallas,  TX  75230
Applicant Contact NANCY BUTCHER
Correspondent
Orametrix, Inc.
12740 Hillcrest Rd., Suite 100
Dallas,  TX  75230
Correspondent Contact NANCY BUTCHER
Regulation Number872.6640
Classification Product Code
EIA  
Date Received08/23/2000
Decision Date 11/16/2000
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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