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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K990306
Device Name HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025
Applicant
Kay See Dental Mfg. Co.
124 E. Missouri Ave.
Kansas City,  MO  64106
Applicant Contact CLARK SMITH
Correspondent
Kay See Dental Mfg. Co.
124 E. Missouri Ave.
Kansas City,  MO  64106
Correspondent Contact CLARK SMITH
Regulation Number872.3765
Classification Product Code
EBC  
Date Received02/01/1999
Decision Date 03/03/1999
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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