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This document is a 510(k) premarket notification approval letter for a dental device, "Veracia." It confirms the device's substantial equivalence to legally marketed predicate devices.

The document does not contain information about acceptance criteria or a study proving the device meets those criteria. It is an approval letter, not a device performance report.

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

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K Number

K113426

Device Name

VERACIA SA

Manufacturer

SHOFU DENTAL CORPORATION

Date Cleared

2012-02-08

(82 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

Used as artificial teeth to produce partial and full dentures.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a dental device called "Veracia SA," which is described as a preformed plastic denture tooth.

This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it pertains to AI/algorithm performance. It is a regulatory approval for a physical dental product, not a software or AI-powered medical device.

Therefore, I cannot provide the requested information for an AI/algorithm-based device from this document.

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