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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Agent, Polishing, Abrasive, Oral Cavity
510(k) Number K875339
Device Name JETPOLISHER AIRPOLISHING POWDER
Applicant
Young Dental Manufacturing Co. 1, LLC
2418 Northline Industrial Blvd.
Maryland Heights,  MO  63043
Applicant Contact SCOTT RICHMOND
Correspondent
Young Dental Manufacturing Co. 1, LLC
2418 Northline Industrial Blvd.
Maryland Heights,  MO  63043
Correspondent Contact SCOTT RICHMOND
Regulation Number872.6030
Classification Product Code
EJR  
Date Received12/30/1987
Decision Date 04/18/1988
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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