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K Number
K143655
Device Name
SICAT OPTIMOTION
Manufacturer
SICAT GMBH & CO. KG
Date Cleared
2015-10-02

(283 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
  • Protection of teeth and restorations from injury due to bruxism.
  • Temporary relief of Temporal Mandibular Disorder (TMD) and bruxism by reducing muscle tension.
  • Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.
Device Description

Not Found

AI/ML Overview

The provided documents do not contain information about the acceptance criteria, reported device performance, or the details of a study proving the device meets acceptance criteria. The documents are a 510(k) clearance letter from the FDA for the SICAT OPTIMOTION device and its Indications for Use.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that the FDA's decision was based on a determination of substantial equivalence to a predicate device, rather than a direct evaluation against specific acceptance criteria presented in a study within this submission.

Therefore, I cannot provide the requested information from the given text.

N/A