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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 K023742
Device Name SCULPTURE PLUS NANO-HYBRID COMPOSITE
Applicant
Pentron Laboratory Technologies
53 N. Plains
Industrial Rd.
Wallingford,  CT  06492 -0724
Applicant Contact ANNMARIE TENERO
Correspondent
Pentron Laboratory Technologies
53 N. Plains
Industrial Rd.
Wallingford,  CT  06492 -0724
Correspondent Contact ANNMARIE TENERO
Regulation Number872.3690
Classification Product Code
EBF  
Date Received11/07/2002
Decision Date 01/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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