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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K943373
Device Name PERMAGEN F/DC
Applicant
ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN,  UT  84095
Applicant Contact L.M. CHATWIN
Correspondent
ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN,  UT  84095
Correspondent Contact L.M. CHATWIN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/13/1994
Decision Date 08/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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