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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K024282
Device Name ACRYLIC
Applicant
Inovativ, LLC
1155 Twin Hills Dr.
Jefferson,  OR  97352
Applicant Contact ROBERT BOWERS
Correspondent
Inovativ, LLC
1155 Twin Hills Dr.
Jefferson,  OR  97352
Correspondent Contact ROBERT BOWERS
Regulation Number872.3770
Classification Product Code
EBG  
Date Received12/23/2002
Decision Date 03/21/2003
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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