Formlabs Quality Policy for the Design and Manufacturing of 3D printing photopolymer resins for biocompatible applications (e.g., dental, audiology, and surgical planning tools) is:

Formlabs is committed to providing safe and effective 3D printing photopolymer resins that comply with all relevant regulations and consistently meet and exceed our customers' expectations. Our company is committed to the continuous improvement of our processes by adhering to an effective quality management system.

Formlabs resins for biocompatible applications are developed in accordance with the following standards:

• ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 14971 Medical devices — Application of risk management to medical devices
• ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process

Contact Sales to request a written statement or technical specification document. For safety and handling, and technical data, visit our Formlabs Stereolithography 3D Printers Tech Specs page. For solvent compatibility information, visit the Solvent compatibility support article.

Formlabs materials for biocompatible applications are developed in accordance with the following standards:

• ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 14971 Medical devices — Application of risk management to medical devices
• ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process

The materials have also passed the requirements for the following biocompatibility risks based on product:

Contact Sales to request a written statement or technical specification document. For safety and handling, and technical data, visit our Formlabs Stereolithography 3D Printers Tech Specs page. For solvent compatibility information, visit the Solvent compatibility support article.

• Support articles:
  • Manuals and documentation (SLA)
  • Manuals and documentation (SLS)
• Formlabs resin Manufacturing Guides, Instructions for Use, and application guides for Formlabs resins for biocompatible applications
• Dental applications
• Medical applications
• Formlabs SDS library

Formlabs resins for biocompatible applications

• ISO 13485:2016 (All)
• Formlabs is registered (Registration Number: 3015491441) with the US FDA. Please see the following FDA Link.
• The Manufacturer of Dental LT Clear Resin and Dental SG Resin (VERTEX-DENTAL B.V.) is registered with the US FDA (Registration Number: 8030452) Please see the following FDA Link.
• The Manufacturer of Denture Base Resin and Denture Teeth Resin (DENTCA Inc.) is registered with the US FDA (Registration Number: 3009312537) Please see the following FDA Link.
• The Manufacturer of Temporary CB Resin (BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG) is registered with the US FDA (Registration number: 9611514) Please see the following FDA Link.

• Formlabs has an MDEL (Medical Device Establishment License): Company ID: 23828
• Formlabs Denture Teeth Resin: License No. 104548
• Formlabs Denture Base Resin: License No. 104714
• Dental LT Clear Resin V2: License No. 109327
• Dental LT Comfort Resin: License No. 109714
• Premium Teeth Resin: License No. 110852
• IBT, IBT Flex, Dental SG, Surgical Guide, and Custom Tray Resins: There are no Medical Device Licenses (MDLs) for these Resins. They are Class I devices and do not require or have them.
• Dental LT Clear Resin: License No. 98431
• The Manufacturer of Dental LT Clear Resin and Dental SG Resin (VERTEX-DENTAL B.V.) has an MDEL (Medical Device Establishment License): Company ID: 128421
• Temporary CB Resin: License No. 102710
• The Manufacturer of Temporary CB Resin (BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG) has an MDEL (Medical Device Establishment License): Company ID: 125184

Formlabs has a Device Master File (MAF) with FDA for BioMed Amber, BioMed Black, BioMed Clear, BioMed Durable, BioMed White, BioMed Flex 50A, and BioMed Flex 80A Resin. Information in the MAF may be referenced in your PMA, 510(k), IDE, or other submissions to FDA. Please contact your sales representative for a letter of authorization.

Formlabs is an industry-leading manufacturer of 3D printers and materials used by healthcare providers to support the practice of medicine. See our Regulatory Information page for details on how Formlabs machines are used to produce preoperative planning models for diagnostic use.

IQ/OQ/PQ calibration tools and templates are available exclusively for Form 3B/3B+, Form 3BL, Fuse 1, and Fuse 1+ 30W customers in the medical sector. Please contact Formlabs to confirm eligibility and request these forms. Maintenance schedules for Formlabs hardware can be found on the Formlabs Support Site.