Dental LT Clear V2 Resin

• K Number: K222061
• Device Name: Dental LT Clear V2 Resin
• Manufacturer: Formlabs Ohio, Inc.
• Date Cleared: 2022-11-10 ( 120 days)
• Product Code: MQC , DYT , KMY
• Regulation Number: N/A
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K203000 , K183598

Intended Use

Dental Clear LT V2 Resin when utilized to print dental or orthodontic appliances such as occlusal splints, night guards, or mouth guards is indicated to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism, respectively.

Device Description

Dental LT Clear V2 Resin is a light-curable polymer-based resin designed for the fabrication of biocompatible, long-term use, removable dental and orthodontic appliances by additive manufacturing.

AI/ML Overview

The provided document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for Dental LT Clear V2 Resin, a light-curable polymer-based resin for fabricating dental and orthodontic appliances.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The non-clinical testing data for the Dental LT Clear V2 Resin is summarized in Table 1 on page 4 of the document.

Technological / Performance Characteristic	Test Method	Acceptance Criteria	Post Cured Results
Flexural modulus	ASTM D790-17	≥ 1 GPa	≥ 2000 MPa
Ultimate tensile strength	ASTM D638-14	≥ 35 MPa	≥ 50 MPa
Elongation	ASTM D638-14	≥ 0.8 %	≥ 10%
Hardness Shore D	ASTM D2240-15	Compliant to ASTM D2240-15	78D
Water Sorption	ISO 20795-2

Regulation Number and Section

N/A