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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 K983168
Device Name AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200
Applicant
Ora Innovations, Inc.
319 SW Washington St., Suite 620
Portland,  OR  97204
Applicant Contact GERALD L COGAN
Correspondent
Ora Innovations, Inc.
319 SW Washington St., Suite 620
Portland,  OR  97204
Correspondent Contact GERALD L COGAN
Regulation Number872.4200
Classification Product Code
EFB  
Date Received09/10/1998
Decision Date 11/18/1998
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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