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K Number
K113426
Device Name
VERACIA SA
Manufacturer
SHOFU DENTAL CORPORATION
Date Cleared
2012-02-08

(82 days)

Product Code
ELM
Regulation Number
872.3590
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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.

§ 872.3590 Preformed plastic denture tooth.

(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). 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.