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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K881091
Device Name OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL
Applicant
Coe Laboratories, Inc.
3737 W. 127th St.
Alsip,  IL  60658
Applicant Contact BRAHMA D SHARMA,PHD
Correspondent
Coe Laboratories, Inc.
3737 W. 127th St.
Alsip,  IL  60658
Correspondent Contact BRAHMA D SHARMA,PHD
Regulation Number872.3660
Classification Product Code
ELW  
Date Received03/08/1988
Decision Date 06/28/1988
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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