K Number
K230098
Device Name
Trusana™
Manufacturer
Date Cleared
2023-04-13

(90 days)

Product Code
Regulation Number
872.3760
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Description
The Trusana device is a light-activated denture base resin, offered in four shades. The Trusana resin is used with patient-specific *.stl files provided by the dental practitioner to fabricate the customized denture bases for removable denture devices using a 3D (additive) printer and curing unit. The proprietary light-curable resin is composed of methylacrylated monomers, methacrylated carboxylic acid, phosphine oxide initiator and pigments for color It is used by dental laboratories and dental practices to make the denture bases for the removable dentures. 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.
More Information

No
The summary describes a 3D printable resin and the associated hardware (printer, curing chamber) for fabricating denture bases. There is no mention of AI or ML being used in the design, manufacturing process control, or any other aspect of the device's function as described. The process relies on patient-specific STL files and standard 3D printing technology.

No.
The device is a resin used to 3D print denture bases, which are components of removable dentures, and is intended for professional dental work. It describes the physical properties of the resin and its use in manufacturing the denture base, not a direct therapeutic function.

No

The Trusana™ resin is a material used for 3D printing denture bases. Its intended use is for the fabrication of dental prosthetics, which are restorative devices, not diagnostic ones. The provided text focuses on its composition, physical properties, and performance in creating a denture base, without any mention of diagnosing a condition.

No

The device description clearly states that Trusana is a light-activated denture base resin, which is a physical material used in 3D printing. It is not software.

Based on the provided information, the Trusana™ resin is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is to "3D print denture base for use in making removable full and partial dentures or overdentures." This describes a material used to fabricate a medical device (dentures) that is placed in the body, not a device used to test samples from the body (in vitro).
  • Device Description: The description details a "light-activated denture base resin" used to "fabricate the customized denture bases." This reinforces its role as a material for manufacturing a physical device.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on the physical and chemical properties of the printed material and its biocompatibility, which are relevant to a material used in a medical device, not an IVD.

Therefore, Trusana™ resin is a material used in the manufacturing of a medical device (dentures), not an IVD.

N/A

Intended Use / Indications for 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.

Product codes

EBI

Device Description

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

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

professional dental work.

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)

Testing was conducted to evaluate the performance of a manufactured denture base, according to requirements of DIN EN ISO 20795-1:2013, Dentistry - Base Polymers.
The following specification requirements of the 3D-printed denture base material samples were tested and have been met:
• Surface characteristics
• Shape capability
• Color and color stability
• Translucency
• Freedom from porosity
• Ultimate Flexural strength
• Flexural bending modulus
• Bonding to synthetic teeth
• Water Sorption
• Solubility
• Validation of no residual MMA monomer.
Validated real-time shelf life of the Trusana resin at time of 510(k) submission is 13 months. Properties tested include chemical and physical characteristics after storage.
An assessment, according to ISO 10993-1, based on extractables and cytotoxicity testing, confirms that Trusana printed denture base is biocompatible and non-toxic and meets the requirements for a device in contact with mucosal membrane for >30 days.
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 Asiga machines. Further, tests based on considerations of the orientation during manufacturing were performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Ultimate Flexural Strength: 65 MPa or more (per ISO 20795-1)
Flexural (Bending) Modulus: 2000 MPa or more (per ISO 20795-1)
Water Sorption: 32 µg/mm3 or less (per ISO 20795-1)
Water Solubility: 1.6 µg/mm3 or less (per ISO 20795-1)
Residual monomer: 0% (per ISO 20795-1)

Predicate Device(s)

K191497, NextDent Denture 3D+, Vertex-Dental BV

Reference Device(s)

none

Predetermined Change Control Plan (PCCP) - All Relevant Information

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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
✖ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K230098 -510(k) Summary

I. SUBMITTER
Submitter Name:Myerson, LLC
Submitter Address:5106 North Ravenswood Avenue
Chicago, IL 60640-2713
Contact Person:James H. Swartout, President & CEO
Email:jswartout@myersontooth.com
Telephone:312.432.8200
Date Prepared:January 11, 2023
II. DEVICE
Trade Name:Trusana™
Common NameDenture Resin
Classification:
Name Number
Product Code
Device ClassDenture Relining, Repairing, or Rebasing Resin 21 CFR 872.3760
EBI
II
III. PREDICATE DEVICE
Primary
Predicate Device:K191497, NextDent Denture 3D+, Vertex-Dental BV
Reference Devicenone

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
Identification | The Trusana device is a light-activated denture base resin, offered
in four shades. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The Trusana resin is used with patient-specific *.stl files provided by
the dental practitioner to fabricate the customized denture bases for
removable denture devices using a 3D (additive) printer and curing
unit.
The proprietary light-curable resin is composed of methylacrylated
monomers, methacrylated carboxylic acid, phosphine oxide initiator
and pigments for color
It is used by dental laboratories and dental practices to make the
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 DEVICEPRIMARY PREDICATE
510(k) NUMBER;
DEVICE NAME;
MANUFACTURERK230098
Trusana™
Myerson, LLCK191497
NextDent Denture 3D+
Vertex-Dental BV
PRODUCT CODE
REGULATORY NAMEEBI
Denture Relining, Repairing, or
Rebasing ResinEBI
Denture Relining, Repairing, or
Rebasing Resin
CLASSIFICATION21 CFR 872.376021 CFR 872.3760
INDICATIONS FOR
USETrusana™ 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.NextDent Denture 3D+ is a light-
cured resin indicated for the
fabrication of denture bases
fabricated in dental laboratories,
including full and partial removable
dentures. The material is an
alternative to traditional heat-cured
and auto polymerization resins.
NextDent Denture 3D+ is intended
exclusively for professional dental
work. Fabrication of denture bases
with NextDent Denture 3D+ requires
a computer-aided and
manufacturing (CAD/CAM) system
that includes the following scanner,
design software, additive printer and
post-cure unit:
Design:
Scanner: 3Shape D900
Design Software: 3Shape Dental-
System 2016 Premium
Printing:
Printer: 3D Systems NextDent 5100
Figure 4®; Software: 3D Sprint
Post-curing:
Post-cure unit: NextDent LC-3D
Print Box
INGREDIENTSLight-curable ResinLight-curable Resin
MANUFACTURING
TECHNOLOGY TYPEAdditiveAdditive
CURED PRODUCT
CHARACTERISTICS:
SterilityNon-sterileNon-sterile
Ultimate Flexural
Strength65 MPa or more (per ISO 20795-
  1.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | 84 MPa (per ISO 20795-1 –
    

company website) |
| Flexural (Bending)
Modulus | 2000 MPa or more (per ISO
20795-1) | 2383 MPa (per ISO 20795-1 –
company website) |
| Water Sorption | 32 µg/mm3 or less (per ISO
20795-1) | 28 µg/mm3 (per ISO 20795-1 –
company website) |
| Water Solubility | 1.6 µg/mm3 or less (per ISO
20795-1) | 0.1 % (w/w) (per ISO 20795-1 –
company website) |
| Residual monomer | 0% (per ISO 20795-1) | 30 days. | |
| 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
Asiga machines. | |
| | Further, tests based on considerations of the orientation during
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.