LogoFDA 510(k) Search
K Number
K211804
Device Name
3Delta Crown
Manufacturer
DeltaMed GmbH
Date Cleared
2021-12-06

(178 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Additive production of permanent anterior and posterior restorations, e.g. - Single-tooth crowns - Veneers, inlays, onlays

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria for a device, a study that proves the device meets acceptance criteria, or any details about device performance metrics, sample sizes, expert qualifications, or ground truth establishment.

The document is an FDA 510(k) clearance letter for a device called "3Delta Crown," manufactured by DeltaMed GmbH. It informs the company that their device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. The "Indications for Use" section lists the intended applications of the 3Delta Crown (additive production of permanent anterior and posterior restorations, such as single-tooth crowns, veneers, inlays, and onlays).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.