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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K021457
Device Name FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL
Applicant
PENTRON CORP.
53 NORTH PLAINS INDUSTRIAL RD.
P.O. BOX 724
WALLINGFORD,  CT  06492
Applicant Contact ANNMARIE TENERO
Correspondent
PENTRON CORP.
53 NORTH PLAINS INDUSTRIAL RD.
P.O. BOX 724
WALLINGFORD,  CT  06492
Correspondent Contact ANNMARIE TENERO
Regulation Number872.3770
Classification Product Code
EBG  
Date Received05/06/2002
Decision Date 08/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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