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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Dental
510(k) Number K923883
Device Name DENTAL OR SURGICAL BUR
Applicant
Stratum Dental Technologies, Inc.
1000 W. Bonanza Rd.
Las Vegas,  NV  89106
Applicant Contact K. L HALL
Correspondent
Stratum Dental Technologies, Inc.
1000 W. Bonanza Rd.
Las Vegas,  NV  89106
Correspondent Contact K. L HALL
Regulation Number872.3240
Classification Product Code
EJL  
Date Received08/04/1992
Decision Date 07/27/1993
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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