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K Number
K183598
Device Name
KeyPrint KeySplint Soft
Manufacturer
Keystone Industries
Date Cleared
2019-11-15

(324 days)

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

The KeyPrint® KeySplint Soft™ device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

The letter primarily focuses on:

  • Confirming that the device (KeyPrint KeySplint Soft) is substantially equivalent to legally marketed predicate devices.
  • Outlining regulatory requirements and general controls that the manufacturer must adhere to.
  • Stating the intended indications for use of the device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications from the provided text.

N/A