LogoFDA 510(k) Search
K Number
K161884
Device Name
Ortho System
Manufacturer
3Shape A/S
Date Cleared
2017-04-19

(282 days)

Product Code
MQC,MOC
Regulation Number
N/A
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

3Shape Ortho System™ is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design of Splints, Mouthguards / Nightguards based on 3D models of the patient's dentition before the start of an orthodontic treatment.

The use of the Ortho System™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided document does not contain information about the acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the 3Shape Ortho System™, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

It includes:

  • Device Name: 3Shape Ortho System™
  • 510(k) Number: K161884
  • Indications for Use: "3Shape Ortho System™ is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design of Splints, Mouthguards / Nightguards based on 3D models of the patient's dentition before the start of an orthodontic treatment." It also states, "The use of the Ortho System™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software."
  • Regulatory Class: Unclassified
  • Product Code: MOC
  • Type of Use: Prescription Use

The letter from the FDA confirms market clearance but does not detail the specific performance acceptance criteria or the studies conducted to demonstrate those criteria. To find this information, you would typically need to consult the full 510(k) submission available via the FDA's website, or a more detailed technical document from 3Shape A/S.

N/A