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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
2017 4 4
2021 2 4
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 3 3
Overheating of Device 2 2
Material Separation 2 4
Defective Component 2 4
Sparking 2 2
Use of Device Problem 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4 4
No Code Available 3 3
Foreign Body In Patient 2 4
Burn(s) 2 2
Fatigue 1 1
Anxiety 1 1
Shaking/Tremors 1 1
Arrhythmia 1 1
Convulsion/Seizure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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