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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K990155
Device Name HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010
Applicant
Kay See Dental Mfg. Co.
124 E. Missouri Ave.
Kansas City,  MO  64106 -1294
Applicant Contact CLARK SMITH
Correspondent
Kay See Dental Mfg. Co.
124 E. Missouri Ave.
Kansas City,  MO  64106 -1294
Correspondent Contact CLARK SMITH
Regulation Number872.3275
Classification Product Code
EMA  
Date Received01/19/1999
Decision Date 02/25/1999
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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