formlabs Dental LT Clear V2 Resin Instruction Manual

: August 14, 2024
: formlabs

Table of Contents

Dental LT Clear V2 Resin
Introduction And Indications For Use
Safety
Performance Characteristics
Specific Manufacturing Considerations
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

INSTRUCTIONS FOR USE
Dental LT Clear V2 Resin Prepared: 01/17/2024 PRNT-0028 Rev 02

Dental LT Clear V2 Resin

| Keep away from sunlight| | Use-by date
---|---|---|---
| Consult Instructions for Use| | European Conformity
| Batch Code| | Catalog Number
| Manufacturer| | Temperature Limit
| Prescription only| | Medical Device
| Environmental hazard| | Warning: Read Safety Information
| Unique device identifier| | Importer
| Indicates the authorized representative in Switzerland| | Authorized representative in the European Community
| Formlabs Ohio Inc.
27800 Lemoyne Rd,
Millbury, OH 43447
USA
+1 617 855 0762
---|---
| EU Importer
Formlabs GmbH
Nalepastr. 18
12459 Berlin, Germany
+49 1573 5993322
| Curaden AG
Amlehnstrasse22
6010 Kriens
Switzerland
| Advena Ltd.
Tower Business Centre
2nd Flr. Tower Street,
Swatar, BKR 4013 Malta

Before printing, refer to the Manufacturing Guide and dental applications guide for this material at support.formlabs.com for printing and post- processing recommendations and requirements to ensure the correct and safe usage of this material. For detailed safety and environmental information, the Safety Data Sheet is available at support.formlabs.com.

Introduction And Indications For Use

INTRODUCTION AND INTENDED PURPOSE
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. It is intended for 3D printing dental and orthodontic appliances such as occlusal splints, night guards, or mouthguards.
INDICATIONS FOR USE
Dental LT Clear V2 Resin when utilized to print dental or orthodontic appliances such as occlusal splints, night guards, or mouthguards is indicated to treat patients diagnosed with Temporomandibular Joint Disorder (TMD) and/or Bruxism, respectively.
CONTRAINDICATIONS
Dental LT Clear V2 Resin should not be used in case of any known allergies or hypersensitivity history to photopolymer resin materials. In case of an allergic reaction, stop use immediately, and consult a physician.
INTENDED PATIENT POPULATION
All patients and populations in which a clinician has prescribed a treatment associated with the intended purpose.
INTENDED USERS
Dental and orthodontic professionals who fabricate dental and orthodontic appliances.
CLINICAL BENEFIT
The clinical benefit of Dental LT Clear V2 Resin is the ability to print dental or orthodontic appliances such as occlusal splints, night guards, or mouthguards.

Safety

RESIN ASSOCIATED WARNINGS
Dental LT Clear V2 Resin (uncured) contains polymerizable monomers.

Please read Dental LT Clear V2 Resin SDS at support.formlabs.com for hazards associated with liquid resin.

RESIN USE ASSOCIATED PRECAUTIONS

Protective glasses and nitrile gloves should be worn while handling resin. For information about the handling of Dental LT Clear V2 Resin please read Safety Data Sheet at support.formlabs.com.

INFORMATION FOR PATIENT SAFETY

The patient should inform the clinician of any known allergy or hypersensitivity history to photopolymer resins.
In case of an allergic reaction, stop use immediately and consult a medical physician.
Do not use appliances if damage or cracks are present.
If signs of extreme wear, deterioration, and/or perforations appear, the appliances should be replaced to avoid material failure and/or potential bodily injury.

Performance Characteristics

For detailed information on the mechanical properties of this material, technical data sheets can be found at support.formlabs.com. Dental LT Clear V2 Resin has been evaluated in accordance with ISO 10993-1:2020 and ISO 7405:2018, and meets the requirements of all applicable biocompatibility testing.

Specific Manufacturing Considerations

Refer to the Manufacturing Guide at support.formlabs.com for printing recommendations and requirements to ensure the correct and safe usage of this material.

Hardware: Formlabs 3D Printer (Laser wavelength: 405nm) and accessories
Software: Formlabs PreForm
Part Orientation: Design guidelines for part orientation during printing can be found in the Manufacturing Guide
Part Thickness: Design guidelines for part thickness can be found in Manufacturing Guide
Recommended Post-Processing Equipment:
Formlabs validated accessories
Formlabs validated washing units with approved solvent
Formlabs validated curing units

REQUIREMENTS
For biocompatibility compliance, Dental LT Clear V2 Resin was validated with a dedicated resin tank, build platform, wash unit, and post-processing equipment that were not mixed with any other resins.
A. PRINTING
Printing guidelines and validated equipment can be found in the Manufacturing Guide at support.formlabs.com.
B. WASHING
Washing guidelines and validated equipment can be found in the Manufacturing Guide.
C. POST-CURING
Post-Curing guidelines and validated equipment can be found in the Manufacturing Guide.
D. SUPPORT REMOVAL
Support marks can cause abrasion if not removed and polished. See the Manufacturing Guide for polishing recommendations.
E. CLEANING & DISINFECTION

Fully post-processed parts can be cleaned using a dedicated soft toothbrush with neutral soap and room-temperature water. Do not use toothpaste or any other cleaning products on parts printed with Dental LT Clear V2 Resin. After cleaning, always inspect parts for any cracks. Discard if any damage or cracks are detected.
The appliances may be cleaned and disinfected according to facility protocols. Tested disinfection method: soaking the finished appliance in fresh 70% IPA for 5 minutes. Do not leave the part in the alcohol solution for longer than 5 minutes. After disinfection inspect the part for damage or cracks to ensure that the integrity of the designed part meets performance requirements.

F. STORAGE

Printed appliances should be stored in closed, opaque, or amber containers. Excess light exposure over time may affect the color and performance of printed appliances.
Store cartridges at 10°C – 25°C (50°F – 77°F). Do not exceed 25°C (77°F) when in storage.
Keep cartridges closed & away from ignition sources.

G. DISPOSAL

Cured resin is non-hazardous and may be disposed of as regular waste.
Follow facility protocols for waste that may be considered biohazardous.
Unused liquid resin & solvents should be disposed of in accordance with local regulations.
Cartridge & contaminated packaging should be disposed of in accordance with local regulations.

H. ADVERSE EVENTS
To report any serious injury (temporary or serious permanent deterioration of health, a serious public health threat, or death), contact Formlabs Inc. (+1 617 855 0762) or your local Competent Authority.