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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 K030743
Device Name ETCHANT 40%
Applicant
CONFI-DENTAL PRODUCTS CO.
416 SOUTH TAYLOR AVE.
LOUISVILLE,  CO  80027 -3028
Applicant Contact STEPHEN RUDOLPH
Correspondent
CONFI-DENTAL PRODUCTS CO.
416 SOUTH TAYLOR AVE.
LOUISVILLE,  CO  80027 -3028
Correspondent Contact STEPHEN RUDOLPH
Regulation Number872.3200
Classification Product Code
KLE  
Date Received03/10/2003
Decision Date 05/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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