RODIN Palette Naturalizing Kit

• K Number: K223365
• Device Name: RODIN Palette Naturalizing Kit
• Manufacturer: Belport Company, Inc., Gingi-Pak
• Date Cleared: 2023-03-27 ( 144 days)
• Product Code: EBD
• Regulation Number: 872.3310
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Characterization of provisionals.

Characterization of direct & indirect composite restorations, acrylic denture base and artificial acrylic teeth.
Characterization of C&B composite resin restorations or acrylic resin.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) clearance letter for the "RODIN Palette Naturalizing Kit" (K223365) does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter primarily focuses on the regulatory clearance of the device, confirming its substantial equivalence to predicate devices and outlining general regulatory requirements. It specifies the "Indications for Use" but does not delve into the technical study details that would typically be found in a submission's performance section.

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

Regulation Number and Section

§ 872.3310 Coating material for resin fillings.

(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.