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Instructions for Use (IFU) for printing aligners with DLP & LCD printers

This document provides application-specific technical guidance for the printing of orthodontic aligner components using 3Dresyns® photopolymer resin systems on DLP and LCD vat photopolymerization printers.

This document does not replace the general IFU documents and applies only to orthodontic-related additive manufacturing workflows.

Important: 3Dresyns resin systems are supplied as professional manufacturing materials for additive manufacturing. They are not placed on the market as finished medical devices, certified medical components, or CE-marked accessories. Any medical device manufactured using these materials remains under the full regulatory responsibility of its legal manufacturer.

Scope of application

This IFU applies to:

  • printing of orthodontic aligner components and thermoforming molds
  • DLP and LCD vat photopolymerization systems
  • 3Dresyns resin systems used within orthodontic manufacturing workflows

This IFU does not apply to:

  • non-orthodontic dental devices
  • laser-based SLA systems unless specifically validated
  • off-label or unvalidated clinical workflows

Nature of aligner printing workflows

Orthodontic aligner production is a highly application-sensitive and multivariable manufacturing process.

Final part performance depends on the interaction between:

  • resin formulation and version
  • printer technology and exposure strategy
  • printing orientation and layer thickness
  • post-processing and post-curing workflow
  • thermoforming conditions

Printed parts must therefore be considered process-dependent manufactured components, whose performance is determined by the complete material–printer–process system, not by intrinsic resin properties alone.

Printer and exposure considerations (DLP & LCD)

DLP and LCD printers expose entire layers simultaneously. As a result:

  • exposure time strongly influences dimensional accuracy
  • overcuring may affect surface fidelity and fit
  • undercuring may reduce mechanical stability and durability

Layer thickness, exposure time and light intensity must be optimized and validated for each printer–resin combination.

Orientation and support strategy

Aligner components or molds should be oriented to:

  • minimize internal stresses
  • reduce layer stepping on functional surfaces
  • ensure uniform curing

Support structures must avoid contact with critical fitting areas whenever possible. Support removal and surface finishing may influence final dimensional accuracy.

Calibration and validation

Prior to production, users must:

  • calibrate exposure parameters for the selected resin and printer
  • validate dimensional accuracy using reference geometries
  • confirm reproducibility across multiple builds

Internal quality controls and documented validation protocols should be implemented to ensure consistency.

Post-processing and post-curing

Post-processing is a critical manufacturing step.

Washing, drying and post-curing conditions directly influence:

  • mechanical behavior
  • surface chemistry
  • biological response
  • long-term stability

Post-processing must strictly follow the qualified workflows defined in the applicable IFU. Deviations may significantly alter performance characteristics.

Biocompatibility and safety considerations

Where materials are positioned for biocompatibility-oriented workflows, users are responsible for:

  • selecting appropriate resin versions
  • following the IFU for biocompatible resins
  • validating cleaning and post-curing effectiveness
  • ensuring that residual reactive substances are adequately reduced

Biocompatibility performance depends on validated processing conditions. The final medical device manufacturer remains solely responsible for device qualification, risk assessment and regulatory compliance under applicable regulations, including Regulation (EU) 2017/745 where applicable.

Quality control and reproducibility

Users should implement internal quality controls including:

  • dimensional checks
  • visual inspection
  • batch traceability
  • documented process validation

Controlled and documented workflows are essential to ensure reproducibility.

Limitations and responsibilities

This IFU provides application-specific technical guidance only.

Users are responsible for:

  • validating part performance within their manufacturing environment
  • ensuring regulatory compliance of any finished medical device
  • conducting appropriate risk assessment and conformity evaluation

3Dresyns does not assume responsibility for clinical outcomes, device certification, CE marking, or regulatory approval of final products manufactured using its materials.

Relationship to other Instructions for Use

This IFU must always be used together with:

In case of discrepancy, the most application-specific IFU prevails.

Governing principle

Orthodontic aligner manufacturing is a multivariable, workflow-dependent process. Final device performance depends on the complete material–printer–process–post-processing system and must be validated and qualified by the legal manufacturer of the finished device.