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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K992011
Device Name SYNEA-HS HIGH SPEED-HANDPIECE
Applicant
A-Dec, Inc.
2601 Crestview Dr.
Newberg,  OR  97132
Applicant Contact PATRICK RIDENOUR
Correspondent
A-Dec, Inc.
2601 Crestview Dr.
Newberg,  OR  97132
Correspondent Contact PATRICK RIDENOUR
Regulation Number872.4200
Classification Product Code
EFB  
Date Received06/15/1999
Decision Date 09/10/1999
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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