REMECURE MODEL CL 15E

• K Number: K023652
• Device Name: REMECURE MODEL CL 15E
• Manufacturer: REMEDENT NV
• Date Cleared: 2003-01-09 ( 71 days)
• Product Code: EBZ
• Regulation Number: 872.6070
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

The Remecure CL-15E produces visible light for the polymerization of dental materials and for tooth whitening.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the Remecure CL-15E device, which is an Ultraviolet Activator for Polymerization.

This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. While it details the device name, regulation number, and indications for use, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about any specific study (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test or training sets).

The FDA's substantial equivalence determination for 510(k) devices often relies on comparisons to predicate devices that have already demonstrated safety and effectiveness, rather than requiring extensive new clinical trial data that would outline such detailed study parameters.

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.