FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This FDA letter confirms substantial equivalence for a Caries Indicator device (K030807), but it does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The letter is a regulatory document affirming that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not include performance data or details of clinical studies.

Therefore, I cannot provide the requested information based on the provided text.

Ask a Question

Ask a specific question about this device

K Number

K030743

Device Name

ETCHANT 40%

Manufacturer

CONFI-DENTAL PRODUCTS CO.

Date Cleared

2003-05-09

(60 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

Etchant 40% is indicated for initiation of the bonding sequence for bonding restorative materials to enamel and/or dentin.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for a dental etching product, not a study report for a device's performance. Therefore, it does not contain the information required to answer your query.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the FDA cleared the "Etchant 40%" by determining it is "substantially equivalent" to existing products, rather than requiring a detailed study proving its performance against acceptance criteria as might be done for novel devices or software regulated as medical devices.

Therefore, I cannot provide:

A table of acceptance criteria and the reported device performance: This document does not describe performance criteria or study results for this specific product.
Sample size used for the test set and the data provenance: No test set information is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth experts are mentioned.
Adjudication method: Not applicable as no study is detailed.
Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
Standalone performance study: Not applicable.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.