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K Number
K240743
Device Name
Peak Universal Bond
Manufacturer
Ultradent Products, Inc.
Date Cleared
2024-03-20

(2 days)

Product Code
KLE
Regulation Number
872.3200
Type
Special
Panel
DE
Reference & Predicate Devices
K230465
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Use for virtually all etching and bonding needs in restorative dentistry for patients of all ages. Peak Universal Bond is used for desensitizing/sealing of tooth structure.

Peak Universal Bond adhesive bonds to the following materials:

  • · Dentin and Enamel
  • · Porcelain, Zirconia
  • Metal
  • · Composite
Device Description

Peak™M Universal Bond is a bottle, syringe, or unit dose delivered bonding resin. It can be used with selfetch or with total etch techniques. It is 7.5% filled with an ethyl alcohol solvent carrier and will cure with most high intensity lights including LEDs. Peak Universal Bond adhesive contains 0.2% chlorhexidine which may ensure long term bond strengths. Its mode of action produces a mechanical occlusion of dentin tubules by the resins, thus reducing tooth hypersensitivity.

AI/ML Overview

This is a 510(k) premarket notification for a resin tooth bonding agent, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for AI/ML performance is not found in this document.

The document discusses the substantial equivalence of the "Peak Universal Bond" device to a predicate device, focusing on its physical properties, technological characteristics, and indications for use in dentistry. It references non-clinical testing performed to establish this equivalence, specifically to ISO standards for bonding agents.

Here's why the requested information cannot be provided from this document:

  • No AI/ML Component: The device, Peak Universal Bond, is a traditional medical device (a resin tooth bonding agent). It does not involve artificial intelligence or machine learning for diagnosis, prognosis, or treatment.
  • Non-Clinical Testing: The "study" mentioned is "verification and validation testing" to show substantial equivalence. This involves testing physical properties according to ISO standards (e.g., ISO 29022 for shear bond strength, SEM imaging for dentinal tubule blockage) and simulated use by dental professionals. This is not a clinical study in the typical sense for AI/ML performance, nor does it generate the metrics you've requested.

Therefore, the specific points of inquiry about acceptance criteria, device performance, sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable and not present in this regulatory submission for a conventional dental bonding agent.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.