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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 K844326
Device Name OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE
Applicant
Coe Laboratories, Inc.
3737 W. 127th St.
Alsip,  IL  60658
Applicant Contact BRAHMA D SHARMA
Correspondent
Coe Laboratories, Inc.
3737 W. 127th St.
Alsip,  IL  60658
Correspondent Contact BRAHMA D SHARMA
Regulation Number872.3690
Classification Product Code
EBF  
Date Received11/07/1984
Decision Date 12/03/1984
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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