Trusana™

K230098 · Myerson, LLC · EBI · Apr 13, 2023 · Dental

Device Facts

• Record ID: K230098
• Device Name: Trusana™
• Applicant: Myerson, LLC
• Product Code: EBI · Dental
• Decision Date: Apr 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Trusana™ resin is intended to 3D print denture base for use in making removable full and partial dentures or overdentures. Trusana™ is intended exclusively for professional dental work. Fabrication of denture bases with Trusana™ requires a computer-aided and manufacturing (CAD/CAM) system using the Asiga MAX UV or Asiga PRO 4K 3D printer in conjunction with the Asiga Flash curing chamber.

Device Story

Trusana is a light-curable resin for 3D printing denture bases; used by dental professionals in labs or clinics. Input consists of patient-specific .stl files; processed via CAD/CAM systems using Asiga MAX UV or Asiga PRO 4K printers and Asiga Flash curing chambers. Output is a customized, biocompatible denture base. Device serves as an alternative to traditional heat-curable or auto-polymerizable resins; benefits include customized fit and efficient additive manufacturing workflow.

Clinical Evidence

Bench testing only. No clinical or animal data required for this device category. Performance validated against ISO 20795-1:2013 requirements, including flexural strength, modulus, water sorption, solubility, and residual monomer content. Biocompatibility confirmed per ISO 10993-1 via extractables and cytotoxicity testing.

Technological Characteristics

Light-curable resin composed of methacrylated monomers, methacrylated carboxylic acid, phosphine oxide initiator, and pigments. Additive manufacturing (3D printing) process. Non-sterile. Complies with ISO 20795-1:2013 (denture base polymers) and ISO 10993-1 (biocompatibility). Packaged in 1L HDPE bottles.

Indications for Use

Indicated for professional dental use in the fabrication of removable full and partial dentures or overdentures via 3D printing.

Regulatory Classification

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.

Predicate Devices

• NextDent Denture 3D+ (K191497)

Submission Summary (Full Text)

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April 13, 2023

Myerson, LLC % Patsy Trisler Regulatory Consultant Trisler Consulting 306 Turnberry Court Lebanon, Indiana 46052

Re: K230098

Trade/Device Name: TrusanaTM Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: January 11, 2023 Received: January 13, 2023

Dear Patsy Trisler:

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael E. Adjodha -S

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

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# Indications for Use

510(k) Number (if known) K230098

Device Name

Trusana™

Indications for Use (Describe)

Trusana™ resin is intended to 3D print denture base for use in making removable full and partial dentures or overdentures. Trusana™ is intended exclusively for professional dental work. Fabrication of denture bases with Trusana™ requires a computer-aided and manufacturing (CAD/CAM) system using the Asiga MAX UV or Asiga PRO 4K 3D printer in conjunction with the Asiga Flash curing chamber.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# K230098 -510(k) Summary

| I. SUBMITTER | |
|------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Submitter Name: | Myerson, LLC |
| Submitter Address: | 5106 North Ravenswood Avenue<br>Chicago, IL 60640-2713 |
| Contact Person: | James H. Swartout, President & CEO |
| Email: | [e-mail] |
| Telephone: | 312.432.8200 |
| Date Prepared: | January 11, 2023 |
| II. DEVICE | |
| Trade Name: | Trusana™ |
| Common Name | Denture Resin |
| Classification:<br>Name Number<br>Product Code<br>Device Class | Denture Relining, Repairing, or Rebasing Resin 21 CFR 872.3760<br>EBI<br>II |
| III. PREDICATE DEVICE | |
| Primary<br>Predicate Device: | K191497, NextDent Denture 3D+, Vertex-Dental BV |
| Reference Device | none |

### IV. INDICATIONS FOR USE STATEMENT

Trusana™ resin is intended to 3D print denture base for use in making removable full and partial dentures or overdentures. Trusana™ is intended exclusively for professional dental work. Fabrication of denture bases with Trusana™ requires a computer-aided and manufacturing (CAD/CAM) system using the Asiga MAX UV or Asiga PRO 4K 3D printer in conjunction with the Asiga Flash curing chamber.

### V. DEVICE DESCRIPTION

| Device<br>Identification | The Trusana device is a light-activated denture base resin, offered<br>in four shades. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The Trusana resin is used with patient-specific *.stl files provided by<br>the dental practitioner to fabricate the customized denture bases for<br>removable denture devices using a 3D (additive) printer and curing<br>unit.<br>The proprietary light-curable resin is composed of methylacrylated<br>monomers, methacrylated carboxylic acid, phosphine oxide initiator<br>and pigments for color<br>It is used by dental laboratories and dental practices to make the<br>denture bases for the removable dentures. |

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| The resin is offered in lightproof 1L high density polyethylene (HDPE) bottles. | | |
|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trusana resin is an alternative material to heat-curable and auto-polymerizable resins. | | |
| VI. SUBSTANTIAL EQUIVALENCE COMPARISON TABLE | | |
| | NEW DEVICE | PRIMARY PREDICATE |
| 510(k) NUMBER;<br>DEVICE NAME;<br>MANUFACTURER | K230098<br>Trusana™<br>Myerson, LLC | K191497<br>NextDent Denture 3D+<br>Vertex-Dental BV |
| PRODUCT CODE<br>REGULATORY NAME | EBI<br>Denture Relining, Repairing, or<br>Rebasing Resin | EBI<br>Denture Relining, Repairing, or<br>Rebasing Resin |
| CLASSIFICATION | 21 CFR 872.3760 | 21 CFR 872.3760 |
| INDICATIONS FOR<br>USE | Trusana™ resin is intended to 3D<br>print denture base for use in<br>making removable full and partial<br>dentures or overdentures.<br>Trusana™ is intended exclusively<br>for professional dental work.<br>Fabrication of denture bases with<br>Trusana™ requires a computer-<br>aided and manufacturing<br>(CAD/CAM) system using the<br>Asiga MAX UV or Asiga PRO 4K<br>3D printer in conjunction with the<br>Asiga Flash curing chamber. | NextDent Denture 3D+ is a light-<br>cured resin indicated for the<br>fabrication of denture bases<br>fabricated in dental laboratories,<br>including full and partial removable<br>dentures. The material is an<br>alternative to traditional heat-cured<br>and auto polymerization resins.<br>NextDent Denture 3D+ is intended<br>exclusively for professional dental<br>work. Fabrication of denture bases<br>with NextDent Denture 3D+ requires<br>a computer-aided and<br>manufacturing (CAD/CAM) system<br>that includes the following scanner,<br>design software, additive printer and<br>post-cure unit:<br>Design:<br>Scanner: 3Shape D900<br>Design Software: 3Shape Dental-<br>System 2016 Premium<br>Printing:<br>Printer: 3D Systems NextDent 5100<br>Figure 4®; Software: 3D Sprint<br>Post-curing:<br>Post-cure unit: NextDent LC-3D<br>Print Box |
| INGREDIENTS | Light-curable Resin | Light-curable Resin |
| MANUFACTURING<br>TECHNOLOGY TYPE | Additive | Additive |
| CURED PRODUCT<br>CHARACTERISTICS: | | |
| Sterility | Non-sterile | Non-sterile |
| Ultimate Flexural<br>Strength | 65 MPa or more (per ISO 20795-<br>1) | 84 MPa (per ISO 20795-1 –<br>company website) |
| Flexural (Bending)<br>Modulus | 2000 MPa or more (per ISO<br>20795-1) | 2383 MPa (per ISO 20795-1 –<br>company website) |
| Water Sorption | 32 µg/mm3 or less (per ISO<br>20795-1) | 28 µg/mm3 (per ISO 20795-1 –<br>company website) |
| Water Solubility | 1.6 µg/mm3 or less (per ISO<br>20795-1) | 0.1 % (w/w) (per ISO 20795-1 –<br>company website) |
| Residual monomer | 0% (per ISO 20795-1) | <0.1% (w/w) (per ISO 20795-1 –<br>company website) |
| Biocompatibility | Biocompatible, according to ISO<br>10993 testing | Biocompatible, according to ISO<br>10993 testing (per company<br>website) |
| VII PERFORMANCE AND SAFETY TESTING | | |
| Animal Testing: | This product category does not require animal testing. | |
| Clinical Testing: | This product category does not require human clinical testing. | |
| Laboratory<br>Testing: | Testing was conducted to evaluate the performance of a<br>manufactured denture base, according to requirements of DIN EN<br>ISO 20795-1:2013, Dentistry - Base Polymers.<br>The following specification requirements of the 3D-printed denture<br>base material samples were tested and have been met:<br>• Surface characteristics<br>• Shape capability<br>• Color and color stability<br>• Translucency<br>• Freedom from porosity<br>• Ultimate Flexural strength<br>• Flexural bending modulus<br>• Bonding to synthetic teeth<br>• Water Sorption<br>• Solubility<br>• Validation of no residual MMA monomer.<br> | |
| Shelf Life Testing: | Validated real-time shelf life of the Trusana resin at time of 510(k)<br>submission is 13 months. Properties tested include chemical and<br>physical characteristics after storage. | |
| Biocompatibility<br>Testing: | An assessment, according to ISO 10993-1, based on extractables<br>and cytotoxicity testing, confirms that Trusana printed denture<br>base is biocompatible and non-toxic and meets the requirements<br>for a device in contact with mucosal membrane for >30 days. | |
| Additive<br>Manufacturing | Testing, according to FDA's guidance Technical Considerations for<br>Additive Manufactured Medical Devices, was performed and<br>results were provided in the 510(k). These tests included<br>evaluation of all relevant properties of the printed resin using the<br>Asiga machines. | |
| | Further, tests based on considerations of the orientation during<br>manufacturing were performed. | |

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#### VIII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES

The intended use, critical specifications, and additive method of manufacturing of Trusana are substantially equivalent to the predicate device. NextDenture 3D+.

While the resin of the predicate is different from Trusana, both are photo-curable resins used in additive manufacturing and are of the same material category.

The additive manufacturing processes both use a resin to fabricate the denture bases using a 3D printer, associated software and curing unit.

The noted differences, in comparison to the predicate device, raise no new questions of safety and effectiveness.

## VIX CONCLUSION

Based on the comparisons provided and the data submitted in this 510(k), it can be concluded Trusana™ is substantially equivalent to the predicate device. Myerson's analysis of the resin and its output compared to the predicate show they have the same intended use and similar technological parameters that meet the requirements of ISO 20795-1:2013.