TRANSCURE, MODEL 2910

• K Number: K022862
• Device Name: TRANSCURE, MODEL 2910
• Manufacturer: KINETIC INSTRUMENTS, INC.
• Date Cleared: 2002-10-18 ( 51 days)
• Product Code: EBZ
• Regulation Number: 872.6070
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Light Activation System for Dental Restorative Resins Visible Inspection of the Oral Cavity

Device Description

Not Found

AI/ML Overview

I'm sorry, but this document does not contain the acceptance criteria or study information you are looking for.

The provided text is an FDA 510(k) clearance letter for a device called "TransCure" (an Ultraviolet Activator for Polymerization). This letter confirms that the device has been found substantially equivalent to a predicate device and can be marketed.

However, it lacks the following crucial information required to answer your request:

• Acceptance Criteria and Reported Device Performance Table: This type of detail is typically found in the 510(k) submission itself or a separate performance study report, not in the clearance letter.
• Details of any study: The letter only mentions the device's classification and its substantial equivalence to a predicate. It does not describe any specific studies (e.g., clinical trials, bench tests, or comparative effectiveness studies) conducted to establish performance.
• Information about sample sizes, data provenance, expert qualifications, ground truth, or adjudication methods. These are elements of a detailed study report.

Therefore, I cannot fulfill your request based on the provided text.

Regulation Number and Section

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.