(113 days)
No
The summary describes a light-curable resin and the associated 3D printing process for fabricating dental appliances. There is no mention of AI or ML being used in the design, manufacturing, or quality control of the resin or the resulting devices. The process relies on digital dental files and a CAD/CAM additive manufacturing process, which are standard digital workflows, not necessarily indicative of AI/ML.
No
Explanation: This device is a light-curable resin used for fabricating dental appliances, which are restorative devices, not therapeutic devices. Therapeutic devices are typically used to treat or prevent a disease or condition.
No
Explanation:
The device is a light-curable resin used for fabricating dental appliances in dental laboratories. It is a material for making dental products, not for diagnosing conditions or diseases.
No
The device description clearly states that Stratasys TrueDent™ is a light-curable resin, which is a physical material. It is used in conjunction with a 3D printer and curing light equipment, which are also hardware components. The 510(k) summary focuses on the material properties and performance testing of the resin, not on software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a light-curable resin for fabricating dental appliances (dentures, crowns, etc.) in dental laboratories. This is a manufacturing process for medical devices, not a diagnostic test performed on biological samples.
- Device Description: The description details the material composition and the manufacturing process (3D printing) for creating physical dental prosthetics. It does not describe a test or assay for analyzing biological specimens.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The device is a material used in the fabrication of medical devices (dental prosthetics), not a diagnostic tool.
N/A
Intended Use / Indications for Use
Stratasys TrueDent™ is a light-curable resin indicated for the fabrication of dental appliances including removable full and partial dentures, denture bases, denture teeth, bridges, crowns, inlays, and veneers in dental laboratories. The material is an alternative to traditional heat-curable and auto polymerizing resins. Stratasys TrueDent™ is intended exclusively for professional dental work.
Product codes (comma separated list FDA assigned to the subject device)
EBI, EBG, PZY, EBF
Device Description
Stratasys TrueDent™ is a light-curable methacrylate-based resin, that enables fabrication of monolithic, high quality, functional, and aesthetic dental appliances, including full and partial removable dentures, denture bases, denture teeth, bridges, crowns, inlays, onlays and veneers in a CAD/CAM additive manufacturing process. This material is intended to be used by trained dental professionals for the fabrication of various dental appliances in a CAD/CAM additive manufacturing process that includes the following components: digital dental files based on a digital impression, a Stratasys Poly Jet 3D printer, and curing light equipment. It is an alternative to traditional heat cured and auto polymerization resins. The predesigned color of the dental appliance is achieved by digitally mixing colored resins. The resins are available in five (5) different base colors (clear, white, cyan, magenta, and yellow). Stratasys TrueDent can be used only with Stratasys J5 Series printers. Stratasys J5 Series printers include a 3D printing system that utilizes PolyJet technology, with drop-on-demand inkjet printing process, 3 print heads, and a UV LED (395nm) curing process. The dental appliance is then cured in the Stratasys TrueDent™ Cure curing chamber and sent back to the dentist for try-in and final adjustment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data submitted to demonstrate substantial equivalence included: shelf life testing, biocompatibility testing, performance testing according to ISO 10477, ISO 4049, and ISO 20795, and other performance tests based on internal procedures. Biological test considerations for this categorization include cytotoxicity, sensitization, acute systemic toxicity, sub-chronic toxicity, implantation, and genotoxicity.
Testing, according to FDA's guidance Technical Considerations for Additive Manufactured Medical Devices, was performed and results were provided in the 510(k). These tests included evaluation of all relevant properties of the printed resin using the permitted machines. Further, tests based on considerations of the orientation during manufacturing were performed.
Stratasys TrueDent has a shelf life of 12 months with on-going real-time validation testing for an ultimate shelf life of 24 months. The shelf-life testing is conducted with bench tests from ISO 20795 and other performance tests based on internal procedures.
For mechanical properties, the subject device as well as the primary predicate and both reference devices were tested in accordance with ISO 20795. ISO 4049, and ISO 10477. The subject device meets the requirements of these standards for flexural strength, flexural modulus, sorption, and solubility, similar to the primary predicate and both reference devices. The flexural strength meets the requirements of ISO 20795, ISO 4049, and ISO 10477, and results are similar to those of the primary predicate. The flexural modulus meets the requirements of ISO 20795 and ISO 4049, and results are similar to those of reference device K201827. The sorption and solubility meet the requirements of ISO 20795, ISO 4049. and ISO 10477, and results are similar to those of reference device K201827 (these values are not available for the primary predicate device and reference device K203641). The mechanical properties results demonstrate that the subject device is substantially equivalent to the predicate and reference devices.
Biocompatibility studies were performed on the subject device in accordance with ISO 7405 and ISO 10993. The subject device is categorized, according to ISO 7405 as a surface device with permanent contact. Biological test considerations for this categorization include cytotoxicity, sensitization, irritation, acute systemic toxicity, sub-chronic toxicity, implantation, and genotoxicity. The subject device was successfully evaluated for all such considerations using testing and scientific rationale. Based on the completed test results, the subject device is deemed biocompatible and meets the requirements of ISO 10993-1. Results of biocompatibility evaluation and testing demonstrate that the subject device is substantially equivalent to the predicate and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 7, 2022
Stratasys Ltd % Melissa Burbage Senior Regulatory Specialist PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K220771
Trade/Device Name: Stratasys TrueDent Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI, EBG, PZY, EBF Dated: April 7, 2022 Received: April 8, 2022
Dear Melissa Burbage:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220771
Device Name
Stratasys TrueDent™
Indications for Use (Describe)
Stratasys TrueDent™ is a light-curable resin indicated for the fabrication of dental appliances including removable full and partial dentures, denture bases, denture teeth, bridges, crowns, inlays, and veneers in dental laboratories. The material is an alternative to traditional heat-curable and auto polymerizing resins. Stratasys TrueDent™ is intended exclusively for professional dental work.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
K220771
Stratasys TrueDent™
Stratasys Ltd.
July 6, 2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Stratasys Ltd. | ||
|---|---|---|---|
| 1 Holtzman Street St. Science Park | |||
| P.O. Box 2496 Rehovot, | |||
| 7612401, Israel | |||
| Telephone: | +972-74-745-4000 | ||
| Fax: | +972-74-745-4001 | ||
| Official Contact | Melanie Glennon, VP Quality & Regulatory Affairs | ||
| Representative/Consultant | Melissa Burbage, Senior Regulatory Specialist | ||
| Kevin A. Thomas, PhD; Floyd G. Larson, MS, MBA | |||
| PaxMed International, LLC | |||
| 12264 El Camino Real, Suite 400 | |||
| San Diego, CA 92130 | |||
| Telephone: | +1 858-792-1235 | ||
| Fax: | +1 858-792-1236 | ||
| Email: | mburbage@paxmed.com | ||
| kthomas@paxmed.com, flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Device Name | Stratasys TrueDent™ |
|---|---|
| Common Name | Resin, Denture, Relining, Repairing, rebasing |
| Regulation Number | 21 CFR 872.3760 |
| Regulation Name | Denture Relining, Repairing, or Rebasing Resin |
| Regulatory Class | Class II |
| Product Code | EBI |
| Secondary Product Codes | EBG, PZY, EBF |
| Classification Panel | Dental |
| Reviewing Office | Office of Health Technology 1 |
| (OHT 1: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices) | |
| Reviewing Division | Division of Health Technology 1 B (Dental and ENT Devices) |
PREDICATE DEVICE INFORMATION
Primary Predicate: K210977, E-Dent 1000 (Flexcera Base & Smile), EnvisionTEC GmbH
Reference Devices: K203641, E-Denture Pro Resin, EnvisionTEC E-Denture Pro K201827, GR-17 Resin System, Pro3dure Medical GmbH
4
510(k) Summary Page 2 of 7
INDICATIONS FOR USE STATEMENT
Stratasys TrueDent™ is a light-curable resin indicated for the fabrication of dental appliances including removable full and partial dentures, denture bases, denture teeth, bridges, crowns, inlays, onlays, and veneers in dental laboratories. The material is an alternative to traditional heat-curable and auto polymerizing resins. Stratasys TrueDent™ is intended exclusively for professional dental work.
SUBJECT DEVICE DESCRIPTION
Stratasys TrueDent™ is a light-curable methacrylate-based resin, that enables fabrication of monolithic, high quality, functional, and aesthetic dental appliances, including full and partial removable dentures, denture bases, denture teeth, bridges, crowns, inlays, onlays and veneers in a CAD/CAM additive manufacturing process. This material is intended to be used by trained dental professionals for the fabrication of various dental appliances in a CAD/CAM additive manufacturing process that includes the following components: digital dental files based on a digital impression, a Stratasys Poly Jet 3D printer, and curing light equipment. It is an alternative to traditional heat cured and auto polymerization resins. The predesigned color of the dental appliance is achieved by digitally mixing colored resins. The resins are available in five (5) different base colors (clear, white, cyan, magenta, and yellow). Stratasys TrueDent can be used only with Stratasys J5 Series printers. Stratasys J5 Series printers include a 3D printing system that utilizes PolyJet technology, with drop-on-demand inkjet printing process, 3 print heads, and a UV LED (395nm) curing process. The dental appliance is then cured in the Stratasys TrueDent™ Cure curing chamber and sent back to the dentist for try-in and final adjustment.
PERFORMANCE DATA
Non-clinical testing data submitted to demonstrate substantial equivalence included: shelf life testing, biocompatibility testing, performance testing according to ISO 10477, ISO 4049, and ISO 20795, and other performance tests based on internal procedures. Biological test considerations for this categorization include cytotoxicity, sensitization, acute systemic toxicity, sub-chronic toxicity, implantation, and genotoxicity.
Testing, according to FDA's guidance Technical Considerations for Additive Manufactured Medical Devices, was performed and results were provided in the 510(k). These tests included evaluation of all relevant properties of the printed resin using the permitted machines. Further, tests based on considerations of the orientation during manufacturing were performed. Additional equipment post-510(k) clearance will be added to the labeling by means of the Quality System and within the company's validation plan.
Stratasys TrueDent has a shelf life of 12 months with on-going real-time validation testing for an ultimate shelf life of 24 months. The shelf-life testing is conducted with bench tests from ISO 20795 and other performance tests based on internal procedures.
EQUIVALENCE TO MARKETED DEVICES
Indications for Use Statements
5
The subject device is indicated for fabrication of dental appliances, including removable full and partial dentures, denture bases, denture teeth and temporary bridges, in dental laboratories. The primary predicate (K210977) also has indications for individual and fixed permanent full single crowns, permanent partial crowns (also known as inlays and onlays) in anterior and posterior region, individual and fixed single veneers, artificial teeth for dental prostheses, individual and removable monolithic full and partial dentures. The slight differences in the language of the subject and primary predicate Indications for Use statements, however, do not affect the intended use. The main difference is that the subject device includes indications for bridges, which is not included in the indications of the primary predicate but is addressed by the reference device K201827. The Indications for Use for both the subject device and primary predicate include statements that the maternative to traditional lightcurable resin and is intended exclusively for professional dental work. Both the subject device and primary predicate require fabrication of these devices using a computer aided design and manufacturing (CAD/CAM) system. The subject device Indications for Use Statement does not list the process components, as it is not necessary that such components be listed in the Statement,
The indications for the reference device K203641 include fabrication of denture bases in dental laboratories for full removable dentures. This is the same indication as the subject device for full removable dentures. Slight differences in the language of the Indications for Use statements for the subject device and the reference device K203641 do not affect the intended use. Both the subject device and the reference device K203641 include statements that the maternative to traditional lightcurable and is intended exclusively for professional dental work. Both the subject device and the reference device K203641 require fabrication of these devices using a computer aided design and manufacturing (CAD/CAM) system.
The indications for the reference device K201827 include fabrication of temporary anterior dental restorations, temporary dental restorations and preformed denture teeth to be used in a denture. This is the same as the subject device for bridges and denture teeth, however, different language is used. Both the subject device and reference device K201827 include statements that the material is an alternative to traditional light-curable resin and is intended exclusively for professional dental work. Both the subject device and reference device K201827 require fabrication of these devices using a computer aided design and manufacturing (CAD/CAM) system, also known as additive manufacturing. The system component that is specified for reference device K201827 is an extra-oral curing light equipment.
Mechanical and Biological Properties
The physical, mechanical, and chemical properties of the subject device, the primary predicate device (K210977) and the two reference devices (K203641 and K201827) are very similar. They all are light-curable, methacrylate-based resins that are cured by UV light. They are all delivered in the form of a liquid intended to be used in additive manufacturing.
The subject device, the primary predicate device (K210977), and the two reference devices (K203641 and K201827) are all used in additive manufacturing processes. The type of printing process for reference device K201827 is unknown as it is not stated in the 510(k) Summary. The subject device, the primary predicate device (K210977), and reference device K203641 utilize a photopolymer resin 3D printing process that prints the material layer by layer. These are similar in that the print geometry is exposed to UV light that cures the material. The subject device is different in that it uses drop on demand (DOD) printing and the primary predicate device (K210977) and reference device K203641 use digital light processing (DLP) printing. DOD and DLP printing are similar in that they both use voxels for printing
6
resolution, print using similar materials (resin), cure the resin with UV light, and print support structures that are removed after printing. The main difference is how the material is printed.
DLP uses a vat of resin and a digital light projector to build parts. The projector flashes UV light onto the layer of resin, selectively solidifying the part. This exposure cures and solidifies the pattern and joins the material to the layer below as the build platform is lowered to create the next layer. To ensure good print quality in monolithic full dentures support structures are built using the same material as the printed part and are removed during post processing. DLP uses the same material color for the entire fabrication, which requires post-processing to apply esthetic treatment (coloring).
DOD printing, as used for the subject device resin, works like an inkjet printer. The printer builds parts by jetting photopolymer droplets onto a build platform and solidifying them with UV light. The printer builds layer on top of layer. Similarly to DLP, support structures are also built to ensure good print quality. however a different material is used for the support material. which is also removed after the printing process. DOD printing allows different colors (same base resin with color agent) to be printed at the same time, which allow esthetic denture bases and teeth to be printed together, eliminating the secondary step of applying light curing color composite pastes or liquids to provide an esthetic result.
The differences in printing technology do not raise different questions of safety and effectiveness, as all manufacturing technologies produce a dental device from light-curing acrylic resins that may appropriately be characterized using standard FDA-recognized mechanical testing and biocompatibility evaluation. Performance testing and biocompatibility testing and evaluation were conducted 220771as appropriate mitigation measures for evaluation of substantial equivalence of the subject device, predicate device and reference devices, and the results demonstrate that the subject device is substantially equivalent.
For mechanical properties, the subject device as well as the primary predicate and both reference devices were tested in accordance with ISO 20795. ISO 4049, and ISO 10477. The subject device meets the requirements of these standards for flexural strength, flexural modulus, sorption, and solubility, similar to the primary predicate and both reference devices. The flexural strength meets the requirements of ISO 20795, ISO 4049, and ISO 10477, and results are similar to those of the primary predicate. The flexural modulus meets the requirements of ISO 20795 and ISO 4049, and results are similar to those of reference device K201827. The sorption and solubility meet the requirements of ISO 20795, ISO 4049. and ISO 10477, and results are similar to those of reference device K201827 (these values are not available for the primary predicate device and reference device K203641). The mechanical properties results demonstrate that the subject device is substantially equivalent to the predicate and reference devices.
Biocompatibility studies were performed on the subject device in accordance with ISO 7405 and ISO 10993. The subject device is categorized, according to ISO 7405 as a surface device with permanent contact. Biological test considerations for this categorization include cytotoxicity, sensitization, irritation, acute systemic toxicity, sub-chronic toxicity, implantation, and genotoxicity. The subject device was successfully evaluated for all such considerations using testing and scientific rationale. Based on the completed test results, the subject device is deemed biocompatible and meets the requirements of ISO 10993-1. Results of biocompatibility evaluation and testing demonstrate that the subject device is substantially equivalent to the predicate and reference devices.
7
| Feature | Subject Device | Primary Predicate
Device | Reference Device | Reference Device | Conclusion |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | Stratasys TrueDent™
Stratasys, Ltd. | E-Dent 1000
EnvisionTEC GmbH
K210977 | E-Denture Pro Resin
EnvisionTEC GmbH
K203641 | GR-17 Resin System
Pro3dure Medical GmbH
K201827 | |
| Product Code | EBI, EBG, PZY, EBF | EBF, EBI, ELM | EBI | EBG, PZY | Similar |
| Regulation | 872.3760: Resin,
Denture, Relining,
Repairing, Rebasing
872.3770: Crown And
Bridge, Temporary
Resin
872.3590: Denture,
Plastic, Teeth
872.3690: Material,
Tooth Shade, Resin | 872.3690: Material,
Tooth Shade, Resin
872.3760: Resin,
Denture, Relining,
Repairing, Rebasing
872.3590: Denture,
Plastic, Teeth | 872.3760: Resin,
Denture, Relining,
Repairing, Rebasing | 872.3770: Crown and
Bridge, Temporary Resin
872.3590: Additively
Manufacture, Preformed,
Resin Denture Teeth | Similar |
| Intended Use | Removable full and
partial dentures, denture
bases, denture teeth,
bridges, crowns, inlays,
onlays, and veneers
dental laboratories. | • Individual and fixed
permanent full single
crowns, permanent
partial crowns in front
and posterior area,
• Individual and fixed
single veneers,
• Artificial teeth for
dental prostheses, which
are used for removable
permanent full dentures,
• Individual and
removable monolithic
full and partial dentures | Removable full dentures | Temporary anterior
dental restorations (crown
and bridge) and denture
teeth. | Similar |
| Indications | Stratasys TrueDent™ is
a light-curable resin
indicated for the
fabrication of dentalremovable full and
partial dentures, denture
bases, denture teeth,
bridges, crowns, inlays,
onlays, and veneers in
dental laboratories. The
material is an
alternative to traditional
heat-curable and auto
polymerizing resins.
Stratasys TrueDent™ is
intended exclusively for
professional dental
work. | E-Dent 1000 is a light-
curable resin indicated
for the fabrication of:
• individual and fixed
permanent full single
crowns, permanent
partial crowns in front
and posterior area,
• individual and fixed
single veneers,
• artificial teeth for
dental prostheses, which
are used for removable
permanent full dentures,
• individual and
removable monolithic
full and partial dentures
in dental laboratories.
The material is an
alternative to traditional
restorative dental
material. E-Dent 1000 is
intended exclusively for
professional dental
work. Fabrication of
dental applications with
E-Dent 1000 requires a
computer aided and
manufacturing
(CAD/CAM) system
that includes the
following components:
digital dental files based
on a digital impression
or in case of artificial
teeth for dental
prostheses the digital
dental files based on
manufacturer's data, a
digital light processing
(DLP) printer, and
curing light equipment. | E-Denture Pro is a light-
curable resin indicated
for the fabrication of
denture bases fabricated
in dental laboratories for
full removable dentures.
The material is an
alternative to traditional
heat-curable and auto
polymerizing resins. E-
Denture Pro is intended
exclusively for
professional dental
work. Fabrication of
denture bases with E-
Denture Pro requires a
computer-aided and
manufacturing
(CAD/CAM) system
that includes the
following components:
digital denture base files
based on a digital
impression, a digital
light processing (DLP)
printer, and curing light
equipment. | The GR-17 Resin System
is a light-curable
polymerizable resin
intended to be used in
conjunction with extra-
oral curing light
equipment.
The GR-17 temporary is
indicated for the
fabrication, by additive
manufacturing, of
temporary anterior dental
restorations.
The GR-17.1 temporary
is indicated for the
fabrication, by additive
manufacturing, of
temporary dental
restorations, and for the
fabrication, by additive
manufacturing, of
preformed denture teeth
to be used in a denture. | Similar |
| Chemical
Description | Methacrylate-based
resin | Methacrylate-based
resin | Methacrylate-based
resin | Methacrylate-based resin | Same |
| Material Type | Light-curable Resin | Light-curable Resin | Light-curable Resin | Light-curable Resin | Same |
| Curing Method | UV Light | UV Light | UV Light | UV Light | Same |
| Product State | Liquid | Liquid | Liquid | Liquid | Same |
| Manufacturing
Technology Type | Additive | Additive | Additive | Additive | Same |
| Product Characteristics | | | | | |
| Standards | ISO 10477
ISO 4049
ISO 20795 | ISO 10477
ISO 4049
ISO 20795 | ISO 20795 | ISO 10477
ISO 4049
ISO 22112 | Similar |
| Physical and
Mechanical
Properties | Flexural Strength
Flexural Modulus
Sorption
Solubility | Flexural Strength
Flexural Modulus
Sorption
Solubility | Flexural Strength
Flexural Modulus
Sorption
Solubility | Flexural Strength
Flexural Modulus
Sorption
Solubility | Same |
| Biocompatibility
Standards | ISO 7405
ISO 10993 | ISO 10993 | ISO 10993 | ISO 7405
ISO 10993 | Similar |
| | Cytotoxicity (Part 5)
Sensitization (Part 10)
Irritation (Part 10)
Systemic Toxicity (Part
11) Genotoxicity (Part
3) | Cytotoxicity (Part 5)
Sensitization (Part 10)
Irritation (Part 10)
Systemic Toxicity (Part
11) | Cytotoxicity (Part 5)
Sensitization (Part 10)
Irritation (Part 10)
Systemic Toxicity (Part
11) | | |
| Workflow | | | | | |
| Additive
Manufacturing | Testing, according to
FDA's guidance
Technical
Considerations for
Additive Manufactured
Medical Devices, was
performed and results
were provided in the
510(k). These tests
included evaluation of
all relevant properties of
the printed resin using
the permitted machines.
Further, tests based on
considerations of the
orientation during
manufacturing were
performed. | Testing, according to
FDA's guidance
Technical
Considerations for
Additive Manufactured
Medical Devices, was
performed and results
were provided in the
510(k). These tests
included evaluation of
all relevant properties of
the printed resin using
the permitted machines.
Further, tests based on
considerations of the
orientation during
manufacturing were
performed. | Testing, according to
FDA's guidance
Technical
Considerations for
Additive Manufactured
Medical Devices, was
performed and results
were provided in the
510(k). These tests
included evaluation of
all relevant properties of
the printed resin using
the permitted machines.
Further, tests based on
considerations of the
orientation during
manufacturing were
performed. | Not stated in summary | Similar |
| Printer | Stratasys J5 DentaJet | EnvisionTECs
Perfactory® 3D-Printer
DLP models designed
and validated for use
with the E-Dent 1000
light cured resin are:
• EnvisionOne
cDLM,with LED
• Micro series, with
LED
• Vida Series, with LED
• P4K Series, with LED
• D4K Series, with LED | EnvisionTECs
Perfactory® 3D-Printer
models designed and
validated for use with
the E-Denture Pro light
cured resin are:
EnvisionOne cDLM,
with LED
Vida Series, with LED
P4K Series, with LED
D4K Series, with LED | Not stated in summary | Similar |
| Post Cure | TrueDent™ Cure | Not listed in summary | Not listed in summary | Curing system such as
Nyomo, Rapidshape,
Envisiontec or Asiga
Systems | Similar |
| How Provided | | | | | |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Shelf Life | 2 years (12 months at
time of submission) | 2 years (4 months at
time of K210977) | 3 years | 2 years | Similar |
| Color options | 5 colors | Base: 5 Shades
Smile: 5 Shades | 6 colors | 7 shades | Similar |
8
9
CONCLUSION
The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, made of the similar materials, and manufactured using additive manufacturing processes. The data included in this submission demonstrate substantial equivalence to the primary predicate and reference devices.