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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
Regulation Description Bone cutting instrument and accessories.
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 7 7
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 2 2
Material Perforation 1 1
Inaccurate Delivery 1 1
Mechanical Problem 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Malposition of Device 1 1
Calibration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Insufficient Information 2 2
Failure of Implant 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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