Instructions for Use (IFU) for Dental laboratory workflows

This document provides application-specific instructions for dental laboratory workflows using 3Dresyns® photopolymer resin systems.

This IFU must be used in conjunction with:

• Instructions for Use (IFU)
• Any relevant printer-specific IFU
• Any relevant application-specific IFU where applicable

This document does not replace the general IFU and applies only to dental laboratory workflows such as models, guides, splints, aligner-related parts, denture-base workflows, gingiva simulation and other laboratory-manufactured dental components where applicable.

This IFU is part of the structured documentation system described in the Medical & Biocompatible 3D Printing Framework, where performance, safety and biocompatibility are defined at system level.

Scope of application

This IFU applies to:

• Dental laboratory additive manufacturing workflows
• Professional use of dental photopolymer systems
• Workflows requiring fit, surface quality, dimensional control and repeatable processing
• SLA, DLP and LCD vat photopolymerization systems unless otherwise specified for a given material

This IFU does not replace:

• Application-specific validation for the intended dental use
• Regulatory obligations of the legal manufacturer
• Biocompatibility evaluation where relevant
• Material-specific TDS, CRT and structured calibration workflows

Nature of dental laboratory workflows

Dental laboratory manufacturing is fit-sensitive and process-dependent. Final performance depends on the full material–printer–process–post-processing chain, including:

• Resin formulation and version
• Printer and optical behavior
• Exposure strategy and layer thickness
• Build orientation and support design
• Cleaning, drying and post-curing conditions
• Laboratory finishing and final validation workflow

Changes to processing conditions may alter fit, stiffness, toughness, surface quality, translucency, color stability, dimensional behavior and residual species profile.

Residual species and oral exposure considerations

Dental applications frequently involve direct or indirect contact with saliva, oral fluids and temperature variations. Under these conditions, residual unreacted species, additives or by-products present within printed parts may be released depending on formulation, polymer conversion and post-processing quality.

Photopolymer conversion is not absolute. A fraction of reactive or non-reactive components may remain trapped within the printed structure and may be mobilized under oral conditions.

• Resin formulation and raw material selection
• Degree of polymer conversion achieved during printing and post-curing
• Effectiveness of cleaning, drying and surface purification
• Geometry and thickness of the printed part
• Accessibility of internal regions to cleaning and curing processes

Important: Materials containing reactive or hazardous components prior to curing may retain residual fractions after processing. These residuals may contribute to extractables and must be considered within the overall risk assessment of the final device.

Monomer Free (MF) resin systems are designed to reduce the presence of reactive residual species at the formulation level, contributing to improved control of extractables when processed under validated conditions.

Workflow objectives

Dental workflows typically require control of one or more of the following:

• Dimensional accuracy and fit
• Surface quality and edge fidelity
• Mechanical behavior matched to the intended application
• Repeatable laboratory processing
• Cleaning and post-curing consistency
• Controlled residual species and surface chemistry where relevant

Application-dependent selection logic

• Use rigid or high-strength systems where stiffness, shape retention and precise geometry are required.
• Use flexible, foldable or elastic systems where controlled deformation, insertion or comfort is required.
• Use soft or gingiva-oriented systems where tissue simulation is required.
• Use castable systems only within validated burnout and downstream laboratory workflows.

Printer and build considerations

• Use validated printer settings for the selected dental material and intended workflow.
• Orient parts to protect critical margins, fitting zones and visible surfaces.
• Minimize support contact on critical functional surfaces.
• Do not modify exposure, orientation or support logic for production parts without re-validating fit and dimensional response.
• Use structured calibration when dimensional fidelity is critical.

Printer output, optical distribution and exposure strategy directly influence polymer conversion, dimensional accuracy and residual species.

Cleaning and post-processing considerations

• Cleaning must remove uncured surface resin without compromising fine geometry or surface detail.
• Post-curing is a critical part of final performance and must follow validated workflow conditions.
• Insufficient post-curing may result in reduced mechanical performance and increased residual species.
• Excessive washing, thermal exposure or aggressive finishing may affect fit, surface finish or intended performance.

Cleaning effectiveness is particularly critical in dental geometries with internal features, undercuts or fine structures where residual resin may remain trapped.

Biocompatibility and regulatory note

Where a dental workflow involves biocompatibility requirements, the relevant biocompatible materials IFU, validated post-processing and the regulatory obligations of the legal manufacturer must be followed.

Biocompatibility in dental applications is not an intrinsic property of the liquid resin but the result of a validated manufacturing workflow including material selection, printing, post-processing and control of residual species.

Printing alone is not sufficient to establish final suitability for regulated use.

Quality control and validation

• Verify fit and dimensional accuracy using controlled reference geometries or laboratory acceptance criteria.
• Validate workflow repeatability across lots, printers and post-processing batches.
• Confirm the final material choice for the intended dental application and laboratory workflow.
• Where relevant, validate surface, mechanical and handling behavior under end-use conditions.
• Where applicable, evaluate extractable and leachable behavior under simulated use conditions.

Interpretation principle

3Dresyns® dental materials are supplied as professional manufacturing materials for laboratory additive manufacturing workflows.

Related documentation

• Instructions for Use (IFU)
• IFU for biocompatible resins
• IFU for aligner printing
• Medical & Biocompatible 3D Printing Framework
• Resources