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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 K863876
Device Name OMNI-FIL
Applicant
Inpromas
17220 SW 85th Ave.
Miami,  FL  33157
Applicant Contact WOLF MERKLEIN
Correspondent
Inpromas
17220 SW 85th Ave.
Miami,  FL  33157
Correspondent Contact WOLF MERKLEIN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received10/06/1986
Decision Date 11/26/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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