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K Number
K170549
Device Name
TOKUYAMA CUREGRACE
Manufacturer
Tokuyama Dental Corporation
Date Cleared
2017-07-05

(131 days)

Product Code
EBI
Regulation Number
872.3760
Type
Traditional
Panel
DE
Reference & Predicate Devices
K073106,K984365
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The TOKUYAMA CUREGRACE device is an acrylic resin used in a variety of dental applications such as:

  • Temporary inlay, crowns and bridges
  • Repair of broken or cracked dentures
  • Denture border extension
  • Replacement of lost denture teeth
  • Adjustment of the occlusal height of resin teeth
Device Description

The TOKUYAMA CUREGRACE device is a self-curing acrylic dental resin used for denture relining, repairing, or rebasing and for temporary crowns and bridges. The device is composed of powder and liquid that is cured by chemical polymerization. The powder is packaged in a plastic bottle, and the liquid is packaged in a glass bottle. The powder comes in four shades designated as A2, A3, Pink, and Live Pink. The device does not come sterile and is not intended to be sterilized prior to use. The TOKUYAMA CUREGRACE device comes with a measuring cup for measuring the powder component and a dropper for dispensing the liquid component.

AI/ML Overview

I am sorry, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter and summary for a dental resin, focusing on its substantial equivalence to predicate devices and non-clinical testing. It explicitly states that "There were no clinical tests performed for the TOKUYAMA CURECRACE device."

Therefore, I cannot provide:

  1. A table of acceptance criteria and reported device performance directly from a study, as no clinical study proving the device meets acceptance criteria is described. The acceptance criteria in this context would be showing substantial equivalence to predicate devices through material properties and non-clinical tests.
  2. Sample size used for the test set or data provenance for a clinical study.
  3. Number of experts used to establish ground truth or their qualifications for a clinical study.
  4. Adjudication method for a clinical study.
  5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Information on standalone performance of an algorithm.
  7. The type of ground truth used from a clinical study.
  8. The sample size for the training set from a clinical study.
  9. How the ground truth for the training set was established from a clinical study.

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.