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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 K770055
Device Name COMPOSITE RESTORATIVE MATERIAL, PRESTIGE
Applicant
Lee Pharmaceuticals
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Lee Pharmaceuticals
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.3690
Classification Product Code
EBF  
Date Received01/11/1977
Decision Date 01/14/1977
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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