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IV. 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.
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Hardware: Formlabs 3D Printer and accessories
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Software: Formlabs PreForm
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Part Orientation: Design guidelines for part orientation during printing can be found in the
Manufacturing Guide
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Part Thickness: Design guidelines for part thickness can be found in Manufacturing Guide
•
Recommended Post-Processing Equipment:
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Formlabs validated accessories
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Formlabs validated washing units with approved solvents
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Formlabs validated curing units
REQUIREMENTS
For biocompatibility compliance, Dental LT Comfort 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 at support.
formlabs.com.
C. POST-CURING
Post-Curing guidelines and validated equipment can be found in the Manufacturing Guide at support.
formlabs.com.
D. SUPPORT REMOVAL
Support marks can cause abrasion if not removed and polished. See Manufacturing Guide
at support.formlabs.com for polishing recommendations.
E. CLEANING & DISINFECTION
1. Appliances may be cleaned using neutral soap and water or effervescent dental appliance
cleaning tablets (used according to the manufacturer's directions).
2. Appliances may be disinfected by soaking in 70% IPA for five minutes per FDA guidelines.
3. Inspect appliances for cracks after cleaning or disinfection. Discard if any damage or cracks are
detected.
F. STORAGE
1. 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.
2. Store cartridges at 10°C - 25°C (50°F - 77°F). Do not exceed 25°C (77°F) when in storage.
3. Keep cartridges closed and away from ignition sources.
G. DISPOSAL
1. Cured resin is non-hazardous and may be disposed of as regular waste.
2. Follow facility protocols for waste that may be considered biohazardous.
3. Unused liquid resin & solvents should be disposed of in accordance with local regulations.
4. Cartridge & contaminated packaging should be disposed of in accordance with local regulations.
H. ADVERSE EVENTS
To report any serious injury (temporary or permanent serious deterioration of health, a serious public
health threat, or death), contact Formlabs Inc. (+1 617 855 0762) or your local Competent Authority.
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