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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K162397
Device Name Titan 3 Low Speed Angle Attachments
Applicant
Dentalez, Inc.
1816 Colonial Village Ln.
Lancaster,  PA  17601
Applicant Contact Dan Laskowitz
Correspondent
Dentalez, Inc.
1816 Colonial Village Ln.
Lancaster,  PA  17601
Correspondent Contact Dan Laskowitz
Regulation Number872.4200
Classification Product Code
EGS  
Date Received08/26/2016
Decision Date 01/19/2017
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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