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K Number
K172398
Device Name
DENTCA DENTURE Teeth
Manufacturer
DENTCA, INC.
Date Cleared
2017-11-22

(106 days)

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

DENTCA Denture Teeth is a light-curable polymerizable resin to fabricate, by additive manufacturing, preformed denture teeth to be used in a denture.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Dentca, Inc. regarding their DENTCA DENTURE Teeth. This document is a regulatory approval letter and does not contain information about acceptance criteria, device performance, or study details like sample sizes, ground truth, or expert qualifications.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based on the provided text.

The document primarily states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. It also lists the Indications for Use for the DENTCA DENTURE Teeth.

§ 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.