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510(k) K162397

Titan 3 Low Speed Angle Attachments by Dentalez, Inc. — Product Code EGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2017
Date Received
August 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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