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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 K931880
Device Name PROFILL LC COMPOSITE
Applicant
Jedental Co., Inc.
16 Shawnee Ln.
Royersford,  PA  19468
Applicant Contact HORACE J WILMER
Correspondent
Jedental Co., Inc.
16 Shawnee Ln.
Royersford,  PA  19468
Correspondent Contact HORACE J WILMER
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/14/1993
Decision Date 07/08/1993
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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