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K Number
K082671
Device Name
HERCULITE ULTRA
Manufacturer
SYBRON DENTAL SPECIALTIES
Date Cleared
2008-12-11

(87 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Herculite Ultra is a dental composite restorative material intended to be used in all classes of cavities.

Device Description

Herculite Ultra is a light-cured, resin-based, dental restorative designed for direct placement. It is indicated for all cavity classes in anterior and posterior teeth.

AI/ML Overview

The provided text is a 510(k) summary for the Herculite Ultra dental composite restorative material. It serves as a regulatory document to demonstrate substantial equivalence to a predicate device and does not contain information about the acceptance criteria or a study proving the device meets those criteria in the way you've outlined.

Specifically, the document focuses on:

  • Device Name and Classification: Herculite Ultra, a dental composite restorative material (21 CFR § 872.3690).
  • Predicate Device: Herculite XRV, Kerr Corporation.
  • Device Description: Light-cured, resin-based, dental restorative for direct placement in all cavity classes.
  • Intended Use: Dental composite restorative material for all classes of cavities.
  • Substantial Equivalence Claim: Herculite Ultra functions similarly to the legally marketed Herculite XRV.
  • FDA Communication: Formal letter from the FDA indicating review of the 510(k) and a determination of substantial equivalence, allowing the device to be marketed.

Therefore, I cannot provide the requested information from the given text because:

  1. Acceptance Criteria and Reported Device Performance: This document does not specify performance acceptance criteria or report specific performance metrics for Herculite Ultra that would be typically found in a clinical or performance study report.
  2. Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document is a regulatory submission summary for substantial equivalence, not a detailed study report. It does not contain information about specific test sets, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.

A 510(k) submission primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This often involves comparing device characteristics (materials, physical properties, intended use) and, where applicable, non-clinical or limited clinical data to show equivalence, rather than establishing de novo performance against acceptance criteria in the way a new drug or novel high-risk device might.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.