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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K172918
Device Name DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)
Applicant
Kavo Dental Technologies, LLC
11727 Fruehauf Dr.
Charlotte,  NC  28273
Applicant Contact Frank Ray
Correspondent
Kavo Dental Technologies, LLC
11727 Fruehauf Dr.
Charlotte,  NC  28273
Correspondent Contact Frank Ray
Regulation Number872.1800
Classification Product Code
MUH  
Date Received09/25/2017
Decision Date 12/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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