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K Number
K121749
Device Name
VERACIA
Manufacturer
SHOFU DENTAL CORPORATION
Date Cleared
2012-09-07

(85 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

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.

§ 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.