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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 K933543
Device Name ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)
Applicant
Jedental Co., Inc.
324 Second St. Pike
Southampton,  PA  18966
Applicant Contact JOHN WONG
Correspondent
Jedental Co., Inc.
324 Second St. Pike
Southampton,  PA  18966
Correspondent Contact JOHN WONG
Regulation Number872.3275
Classification Product Code
EMA  
Date Received07/20/1993
Decision Date 11/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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