LogoFDA 510(k) Search
K Number
K101814
Device Name
DIRECT CROWN NATURAL 1
Manufacturer
CANDULOR USA, INC.
Date Cleared
2010-09-27

(90 days)

Product Code
EBG
Regulation Number
872.3770
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Direct Crown Natural 1 is intended for the fabrication of short and long term temporary crowns and bridges (up to 12 months) using the Direct Crown shell teeth.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental device called "Direct Crown Natural 1," which is a temporary crown and bridge resin.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not describe:

  • Acceptance criteria and reported device performance (in a table or otherwise).
  • Details of any study (sample size, data provenance, expert qualifications, ground truth establishment, MRMC studies, standalone performance, training set size).

The document is purely an FDA clearance notification, not a study report or clinical trial summary.

Therefore, I cannot provide the requested table or answer the specific questions about device performance studies based on the provided text.

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.