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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dental navigation system
Definition Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures.
Product CodeQRY
Regulation Number 872.4120
Device Class 2


Premarket Reviews
ManufacturerDecision
NEOCIS INC.
  SUBSTANTIALLY EQUIVALENT 2
X-NAV TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2023 17 17
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 6 6
Adverse Event Without Identified Device or Use Problem 4 4
Calibration Problem 3 3
Failure to Calibrate 3 3
Off-Label Use 1 1
Malposition of Device 1 1
Insufficient Information 1 1
Material Perforation 1 1
Product Quality Problem 1 1
Inaccurate Delivery 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
Insufficient Information 2 2
Laceration(s) 2 2
Failure of Implant 1 1
Implant Pain 1 1
Physical Entrapment 1 1

Recalls
Manufacturer Recall Class Date Posted
1 X-NAV Technologies, LLC II Mar-29-2024
2 X-NAV Technologies, LLC II Nov-10-2022
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