RODIN 3D Resin SPLINT, Hard/Flex

• K Number: K231793
• Device Name: RODIN 3D Resin SPLINT, Hard/Flex
• Manufacturer: Belport Company, Inc., Gingi-Pak
• Date Cleared: 2024-03-26 ( 280 days)
• Product Code: MQC , KMY
• Regulation Number: N/A
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

RODIN Splint is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, splints and repositioners.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental resin material, RODIN 3D Resin SPLINT, Hard/Flex. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/ML powered device.

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

Regulation Number and Section

N/A