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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 K863882
Device Name OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE
Applicant
Coe Laboratories, Inc.
3737 W. 127th St.
Alsip,  IL  60658
Applicant Contact SHARMA, PH.D.
Correspondent
Coe Laboratories, Inc.
3737 W. 127th St.
Alsip,  IL  60658
Correspondent Contact SHARMA, PH.D.
Regulation Number872.3690
Classification Product Code
EBF  
Date Received10/06/1986
Decision Date 11/18/1986
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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