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K Number
K022969
Device Name
UNIVERSAL CERAMIC SOLDER
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2002-10-18

(42 days)

Product Code
EJT
Regulation Number
872.3060
Type
Traditional
Panel
DE
Reference & Predicate Devices
k003416
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Used for brazing dental alloys prior to porcelain application.

Device Description

Not Found

AI/ML Overview

This is an FDA 510(k) clearance letter for a dental device (Universal Ceramic Solder) from 2002. It refers to the device's substantial equivalence to a legally marketed predicate device. This type of document, particularly from this era, typically does not contain detailed primary study data, acceptance criteria, or ground truth methodologies that are common in more recent AI/ML device submissions.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be provided:

  1. A table of acceptance criteria and the reported device performance:

    • Cannot be provided. This document does not detail specific acceptance criteria or performance metrics for the Universal Ceramic Solder. The clearance is based on "substantial equivalence" to a predicate device, which implies the new device performs similarly without necessarily requiring extensive new performance data to be reported in the 510(k) summary (especially for devices in 2002).

  2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

    • Cannot be provided. The document does not mention any specific test sets, sample sizes, or data provenance.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

    • Cannot be provided. No information about ground truth establishment or experts is present.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Cannot be provided. No adjudication method is mentioned.

  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • Cannot be provided. This is a clearance for a physical dental solder, not an AI-assisted diagnostic device. MRMC studies and AI assistance are not relevant to this device.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Cannot be provided. This is not an algorithm or AI device.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

    • Cannot be provided. No information about ground truth is present. For a traditional material like a ceramic solder, performance would typically be assessed by material properties (e.g., bond strength, biocompatibility) rather than ground truth in the sense of diagnostic accuracy.

  8. The sample size for the training set:

    • Cannot be provided. This is not an AI/ML device requiring a training set.

  9. How the ground truth for the training set was established:

    • Cannot be provided. Not applicable.

§ 872.3060 Noble metal alloy.

(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are 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.