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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 K974413
Device Name PERMAFLO
Applicant
ULTRADENT PRODUCTS, INC.
505 W. 10200 SO.
SOUTH JORDAN,  UT  84095 -3935
Applicant Contact CHESTER MCCOY
Correspondent
ULTRADENT PRODUCTS, INC.
505 W. 10200 SO.
SOUTH JORDAN,  UT  84095 -3935
Correspondent Contact CHESTER MCCOY
Regulation Number872.3690
Classification Product Code
EBF  
Date Received11/24/1997
Decision Date 02/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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