Actually, there is no such thing as an "FDA Approved" resin for 3D printing. The term "FDA Approved" is reserved for high risk drugs and medical devices which have been approved via a very stringent premarket approval (PMA) process that goes well beyond the standard FDA 510(k) pathway. Read the article below on the FDA website for this very important distinction:
What is the difference between FDA-listed, 510(k) exempt, cleared and approved medical devices? (fda.gov archived)
FDA "Exempt" Biocompatible Class 1 Dental Resins
Most 3D printer resins used in dentistry today are exempt from the FDA 510(k) process, although the FDA requires that the source specifically list them as exempt before marketing them. 3D Printed resins marked as FDA 510(k) Exempt have been tested by the manufacturer to be biocompatible and are listed by that manufacturer or distributor for tracking purposes. In this case, it is the manufacturer, not the FDA, that is claiming that these products are exempt from the FDA 510(k) process, usually because they make limited contact with the patient.
In general, FDA 510K Exempt 3d printer resins must use ingredients that have been tested for biocompatibility (ie. cytotoxicity and other ISO 10993 testing), and are thus considered to not present a high risk to the patient when used in most Class 1 and some Class 2 dental indications where exemption from the 510(k) requirements is allowed.
In order for a resin to be listed as 510(k) Exempt, the manufacturer or distributor needs to have a Establishment Registration with the FDA, which indicates that the manufacturer is using a modern quality system and which allows the FDA to regularly audit the organization. Additionally, the packaging and labelling must meet FDA guidelines. Establishment registation requires a $4000+ annual fee and proof that the quality system meets minimal FDA guidelines. After the establishment is registered, the company can list their 510K exempt resins which will allow those products to be sold, shipped and monitored. Most importantly, these exemption listings are required for importing through customs, plus they allow all parties to track complaints about a specific resin back to the manufacturer.
510(k) FDA Listed or FDA Cleared Dental Resins
If a product is identified as "FDA Listed" or "FDA-Listed," it means that the company who manufacturers or distributes it has completed an online listing theur the FDA Unitifed Registration and Listing System (FURLS). The term "FDA Cleared" refers to the subset of products that were cleared by the FDA because of a claim by the manufacturer or distributor that the product is substantially equivalent to another leglally marketed dental device. A 510K is substantiated by testing and it allows the resin to be used for a very narrow set of dental uses or indications. The listing may also specific very specific printing and post-processing steps needed to achieve the results demonstrated to the FDA in the testing process, including naming specific machines or means, so it is up to the user to make sure that they are processing the material in the same manner as was indicated. Any variation from the declared indications and processes is considered "off label" use.
List of FDA Tracked Dental 3D Printer Resins
The table below identifies 3d printable resins with can be legally imported into the US because they have been 510K listed or determined to be Class I devices and therefore exempt from the FDA 510K clearance process. Manufacturer's update their own product listings every year, and can modify the list throughout the year, so the information above can be fluid as they rebrand and re-role the products (ie. start exporting, etc).
If you are aware of other FDA exemptions, clearances or listings in dental 3d printing, please send us an email via our contact form and we will add it to the list.
|Establishment||Indication||Proprietary Names||Class||510(k)||Role or Equivalence|
|VarseoWax Surgical Guide (482884)||1-NDP||Exempt||Foreign Exporter;
|Bego||Custom Tray||VarseoWax Tray (537052)||1-EHY||Exempt||Foreign Exporter;
|Bego||Aligners||VarseoSmile Splint (549382)||1-KMY||Exempt||Manufacturer|
|Vertex (8030452)||Denture Base||Denture E-Denture (541062)||2-EBI||K162572
|Eq: Dentca Denture
|Vertex||Retainers||LT Clear; E-Guard; Ortho Clear; Rigid (483000)||1-DYT||Exempt||Manufacturer|
|Vertex||Temporaries||NextDent C&B; C&B MFH (483001)||1-ELK||Exempt||Manufacturer|
|Vertex||Temporaries||E-Dent 400; NextDent C&B; C&B MFH (483002)||2-ELJ||Exempt||Manufacturer|
|Vertex||Surgical Guide||E-Guide Tint; NextDent SG (504122)||1-NPD||Exempt||Manufacturer|
|Dentca (3009312537)||Custom Tray||Dentca Tray (437719)||1-EHY||Exempt||Manufacturer;
|Dentca||Denture Teeth||Denture Teeth (540012)||1-ELM||Exempt||Manufacturer|
|Dentca||Denture Base||Denture Base||2-EBI||K143033
|Dentca||Denture Base||Denture Base II (539033)||2-EBI||K162044
Base #1 (K143033)
|DeltaMed (3002789526)||Temporaries||e-Dent Temporary Resin (311115)||2-EBG||K102776
|Eq: Vita CAD TEMP|
|EnvisionTec (3012389497)||Night Guard||EGuard (516947)||1-DYT||Exempt||Manufacturer|
|EnvisionTec||Surgical Guide||EGuide (517520)||1-NDP||Exempt||Manufacturer|
|Structo (3014329597)||Surgical Guide||Structomer Guide (563712)||1-NDP||Exempt||Manufacturer|
|Dentis (3007031098)||Impression Tray||Z-Clear/SG, Z-Model, ZMD-1000B (479599)||1-EBH||Exempt||Manufacturer|
|Dentis||Wax Cast||Z-Castable, ZMD-100B Castable (479502)||1-EGD||Exempt||Manufacturer|
|Dreve (1000486347)||Temporaries||Multiple (266258)||1-EBH||Exempt||Contract Manufacturer;
|Dreve||Surgical Guide||FotoDent Guide; Multiple (459759)||1-NDP||Exempt||Contract Manufacturer;
|Dreve||Custom Tray||Multiple (266258)||1-EBH||Exempt||Contract Manufacturer;
These companies currently have FDA establishment listings with 3D printable resins:
- Bego Bremer (9611514)
- Vertex-Dental (8030452)
- Dentca, Inc. (3009312537)
- Dentis (3007031098)
- DeltaMed (3002789526)
- Dreve (1000486347)
- Keystone (many, search "Keyprint" soon)
- Structo (3014329597)
- Whip Mix (3007057241)
Use this link to search establishment listings:
These companies resell, relabel or specify other manufacturer's resins, with or without their own FDA establishment licenses.
- Formlabs - relabels NextDent resins
- EnvisionTec - relabels NextDent as "E-Guard" and DeltaMed as "E-Dent"
- Whip Mix - relabels Dreve (also makes Carbon SG resin for Carbon)
- Sprintray - relabels NextDent and Dentis
- Roland - relabels NextDent resins
- Carbon - WhipMix and Dentca resins
The indications and/or categories of resins below do not currently require FDA listings by their manufacturers as the devices created with these resins do not require biocompatibility:
- Dental Models - Resins for dental restorative models and dies
- Ortho Models - Resins for orthodontic models, indirect bonding bracket trays , or where the final splint is created via theraforming
- Gingival Masks - Resins for flexible gingival model inserts
- Wax Cast - Resins for creating metal substructures and RPDs via loss-wax process
Regulatory Guidance Links
The FDA developed specific guidance for 510(k) submission regarding dental resins in 2005 in the PDF below:
- Guidance for Industry and FDA Staff - Dental Composite Resin Devices - Premarket Notification [510(k)] SubmissionsDental Composite Resin Devices - Premarket Notification [510(k)] Submissions
CURRENT US FDA DRAFT GUIDANCE ON 3D PRINTING
- "Technical Considerations for Additive Manufactured Medical Devices"
Draft Guidance dated Dec 5, 2017 (first draft originally issued May 10, 2016) - 34 pages
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdfUS FDA SIG GUIDANCE ON MEDICAL MODELS
Aug 2017 Anantomical Model RSNA SIG Meeting
Including webcast and powerpoint links
Below are some papers and powerpoints that were presented to the FDA as part of developing the guidance for medical models:
- FDA 2014 Powerpoint - //www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm418391.pdf" target="_blank" rel="noopener" data-saferedirecturl="https://www.google.com/url?hl=en&q=https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm418391.pdf&;source=gmail&ust=1523465299637000&usg=AFQjCNEt98mSHcRmbF8G6CpKi5UDfBd6kg">https://www.fda.gov/ucm/groups
/fdagov-public/@fdagov-meddev- gen/documents/document/ucm4183 91.pdf
- SIG Paper - https://threedmedprint.sprin
- Stratasys Powerpoint - https://www.fda.gov/downloads/
- 3D Systems Powerpoint - https://www.fda.gov/download
ISO / ANSI STANDARDS
- "Standardization Roadmap for Additive Manufacturing, Version 2.0"
AMSC 18-001 - Preliminary Final Draft as of 4/6/18 - 260 pages
CHINESE FDA (CFDA) GUIDANCE
Customized Additive Manufacturing Medical Device Registration - Technical Review Guidelines (Exposure Draft) - March 2018
- Emergo Article - https://www.emergobyul.com/blog/2018/03/new-guidance-china-fda-3d-printed-medical-device-registration-rules-0
- Guidance page (chinese) - http://www.cmde.org.cn/CL0063/6954.html
- Guidance Doc (in Chinese Word Doc) - http://www.cmde.org.cn/directory/web/WS01/images/uL28jG2qNbGyr3U9rLE1sbU7NK9wcbG99C116Ky4by8yvXJ87Lp1ri1vNSt1PKjqNX3xPS4rz7uOWjqS5kb2N4.docx
Chinese FDA has historically been one of the toughest medical regulatory climates in the world for outsiders who want to get medical devices approved for sale in China. Read the emergo article above for key bullet points on the new proposed guidance.
SOFTWARE STANDARDS AND FDA GUIDANCE
- 2002 FDA Guidance on Software Guidance - https://www.fda.gov/downloads/
MedicalDevices/DeviceRegulatio nandGuidance/GuidanceDocuments /ucm085371.pdf
- 2005 FDA Guidance on Software in Medical Devices - https://www.fda.gov/
downloads/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/ucm089593.
FDA GUIDANCE ON DENTAL RESINS
- 2005 Guidance on 510(k) for Permanent Dental Composite Resins - https://www.fda.gov/MedicalDevices/ucm071576.htm
THE FDA REGULATORY PROCESS
- QSR 820 Quality System - https://www.fda.gov/
MedicalDevices/ DeviceRegulationandGuidance/ PostmarketRequirements/ QualitySystemsRegulations/ default.htm
- Establishment Registration & Listings - https://www.fda.gov/
MedicalDevices/ DeviceRegulationandGuidance/ HowtoMarketYourDevice/ RegistrationandListing/ default.htm
- 510K - https://www.fda.gov/
MedicalDevices/ DeviceRegulationandGuidance/ HowtoMarketYourDevice/ PremarketSubmissions/ PremarketNotification510k/ default.htm
Disclaimer - Micron Inc is not affiliated with 3D Systems -- NextDent products are distributed in North America by Avadent.