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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K143694
Device Name Rhondium One-Visit-Crown(OVC)
Applicant
Rhondium, Ltd.
4 Sheffield St.
Katikati,  NZ 3129
Applicant Contact Greer Fricker
Correspondent
Paxmed International, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin A Thomas
Regulation Number872.3690
Classification Product Code
EBF  
Date Received12/24/2014
Decision Date 05/15/2015
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
Recalls CDRH Recalls
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