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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K896843
Device Name EXPLORER 24 DENTAL HAND INSTRUMENT
Applicant
American Medical Ceramics, Inc.
408 Cedar Bluff Rd., Suite
385
Knoxville,  TN  37923
Applicant Contact SAM C WEAVER
Correspondent
American Medical Ceramics, Inc.
408 Cedar Bluff Rd., Suite
385
Knoxville,  TN  37923
Correspondent Contact SAM C WEAVER
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received12/06/1989
Decision Date 03/06/1990
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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