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K Number
K030161
Device Name
SUPERBOND
Manufacturer
AMERICAN DENT-ALL, INC.
Date Cleared
2003-03-17

(60 days)

Product Code
EJH
Regulation Number
872.3710
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Superbond (Ceramic Dental Casting Alloy) is for the use in Dental Laboratories, suitable for use in fabrication of metal-ceramic dental restoration.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for a dental alloy named "Superbond". It's a regulatory approval, not a scientific study report describing acceptance criteria and device performance in the way you've outlined. Therefore, I cannot extract the requested information from the provided text.

The document primarily focuses on:

  • Device identification: Superbond, a Ceramic Dental Casting Alloy.
  • Regulatory classification: Class II, Product Code EJH.
  • Substantial equivalence determination: The FDA found it substantially equivalent to legally marketed predicate devices.
  • Intended use: For use in Dental Laboratories, suitable for use in the fabrication of metal-ceramic dental restoration.
  • Regulatory compliance: Information about general controls provisions and other FDA regulations.

It does not contain any information about:

  • Specific acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity).
  • Results of a study proving the device meets acceptance criteria.
  • Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
  • MRMC studies or standalone algorithm performance.
  • Ground truth types or training set details.

To address your request, a different type of document, such as a clinical study report, a technical performance study report, or the 510(k) summary (which sometimes includes more detail on performance data if applicable to the device type), would be needed.

§ 872.3710 Base metal alloy.

(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.