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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 K102234
Device Name A-DEC 200 DENTAL SYSTEM
Applicant
A-Dec, Inc.
2601 Crestview Dr.
Newberg,  OR  97132
Applicant Contact THOMAS H LOUISELL
Correspondent
A-Dec, Inc.
2601 Crestview Dr.
Newberg,  OR  97132
Correspondent Contact THOMAS H LOUISELL
Regulation Number872.6640
Classification Product Code
EIA  
Date Received08/09/2010
Decision Date 11/24/2010
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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