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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 K001623
Device Name SCULPTURE FLOW
Applicant
Jeneric/Pentron, Inc.
53 N. Plains
Industrial Rd.
Wallingford,  CT  06492
Applicant Contact ANNMARIE TENERO
Correspondent
Jeneric/Pentron, Inc.
53 N. Plains
Industrial Rd.
Wallingford,  CT  06492
Correspondent Contact ANNMARIE TENERO
Regulation Number872.3690
Classification Product Code
EBF  
Date Received05/26/2000
Decision Date 07/11/2000
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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