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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dental stereotaxic instrument
510(k) Number K213392
Device Name INLIANT Surgical Navigation System
Navigate Surgical Technologies Inc.
302 - 25 E. 6th Ave.
Vancouver,  CA V5T 1J3
Applicant Contact Marty Dymek
Pamela Buckman, MSN
921 Calle Verde
Martinez,  CA  94553
Correspondent Contact Pamela Buckman
Regulation Number872.4120
Classification Product Code
Date Received10/15/2021
Decision Date 02/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No