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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K192412
Device Name SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece
Applicant
Dentalez, Inc.
1816 Colonial Village Ln.
Lancaster,  PA  17601
Applicant Contact Robert Young
Correspondent
Dentalez, Inc.
1816 Colonial Village Ln.
Lancaster,  PA  17601
Correspondent Contact Robert Young
Regulation Number872.4200
Classification Product Code
EFB  
Date Received09/04/2019
Decision Date 01/06/2020
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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