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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations
Definition An optical impression system for cad/cam of dental restorations is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.
Product CodeNOF
Regulation Number 872.3661
Device Class 2

MDR Year MDR Reports MDR Events
2021 2 4
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 2 4
Overheating of Device 2 2
Defective Component 2 4
Sparking 2 2
Appropriate Term/Code Not Available 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 2 2
Foreign Body In Patient 2 4
Convulsion/Seizure 1 1
Unspecified Ear or Labyrinth Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Eye Injury 1 1
Fatigue 1 1
Nausea 1 1
Dizziness 1 1
Anxiety 1 1
Shaking/Tremors 1 1
Arrhythmia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CARESTREAM DENTAL, LLC II Mar-17-2021
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