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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 K092851
Device Name MODEL GDCH-2000
Applicant
Global Dental Direct, Inc.
2120 Paramount Crescent
Suite 4
Abbotsford, Bc,  CA V2T-6A5
Applicant Contact DON TEMPLE
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact JAY Y KOGOMA
Regulation Number872.6640
Classification Product Code
EIA  
Date Received09/16/2009
Decision Date 09/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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