VarseoSmile TriniQ is indicated as an indirect restorative for both anterior restorations, including occlusal surfaces. The VarseoSmile TriniQ material is used for fabricating permanent restorations such as inlays, veneers, full crown and bridge restorations. VarseoSmile TriniQ can also be used for the fabrication of artificial teeth and temporary crowns & bridges.

Device Description

The Subject device is a light-cured methacrylate-based resin used in 3D printers to produce permanent or dental restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations including occlusal surfaces. The Subject device is used by a dental technician for the CAD/CAM manufacturing of temporary or permanent dental restorations. Restorations fabricated using the Subject device are one-time use, prescription-only devices. Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration. Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical, and biocompatible properties. The Subject device is intended to be sold by the bottle and used with compatible hardware in computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.

AI/ML Overview

The provided text describes the acceptance criteria and study for the VarseoSmile TriniQ device. This device is a light-cured methacrylate-based resin used in 3D printers to produce dental restorations.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the device was tested against and met the requirements of specific ISO standards. It mentions a flexural strength criterion.

Acceptance Criterion	Reported Device Performance
ISO 4049:2019 (Dentistry — Polymer-based restorative materials)	Met requirements
ISO 10477:2020 (Dentistry – Polymer-based crown and veneering materials)	Met requirements
ISO 22112:2017 (Dentistry – Artificial teeth for dental prostheses)	Met requirements (in most cases; comparative testing used where not met)
Flexural Strength	≥ 100 MPa
Biological Evaluation	Met requirements based on ISO 10993-1, 10993-5, 10993-10, 10993-17, 10993-18, 10993-23, and ISO/TS 21726
MRI Safety	Met requirements based on FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment"
Manufacturing Process Consistency	Demonstrated consistency of the process output with that of the process input

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not specify the sample size used for the test set in terms of the number of dental restorations or materials tested for each performance criterion. It generally refers to "Physical property testing" and "Confirmatory testing" without providing specific numbers of samples.

The data provenance is non-clinical performance testing, meaning it's laboratory-based testing of the material's properties rather than human patient data. There is no mention of country of origin for the data; the testing is against international ISO standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not applicable and therefore, not provided. The testing described is for material characteristics against engineering and biocompatibility standards, not for diagnostic accuracy or clinical outcomes that would require expert-established ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore, not provided. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, not for laboratory material property testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This information is not applicable and therefore, not provided. The device described is a dental restorative material, not an AI-powered diagnostic or treatment assistance tool. No MRMC study was mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable and therefore, not provided. The device is a material, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical performance testing is the established requirements and specifications defined by international ISO standards (e.g., ISO 4049, ISO 10477, ISO 22112, ISO 10993 series) and FDA guidance for MRI safety. For manufacturing process validation, the ground truth is the expected or desired output consistent with the process input.

8. The Sample Size for the Training Set:

This information is not applicable and therefore, not provided. This is a material, not a machine learning model, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable and therefore, not provided. As there is no training set mentioned, there is no ground truth to be established for it.

Summary

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November 9, 2023

BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K233596

Trade/Device Name: VarseoSmile TriniQ Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF, EBG, PZY Dated: November 8, 2023 Received: November 8, 2023

Dear Prithul Bom:

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.

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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 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 medical devices and radiation-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).

Sincerelv.

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA 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)

K233596

Device Name VarseoSmile TriniQ

Indications for Use (Describe)

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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ADMINISTRATIVE INFORMATION

Manufacturer Name:	Consultant:
BEGO Bremer Goldschlägerei Wilh.Herbst GmbH & Co. KGWilhelm-Herbst-Straße 128359 Bremen, GermanyTelephone: +49 421 2028-157	Aclivi, LLC3250 Brackley DriveAnn Arbor, Michigan 48105Telephone: +1 810 360-9773
Official Contact:	Marius Kempf - Team Leader PM 3D Printing	Chris Brown - Manager
Email:	marius.kempf@bego.com	acliviconsulting@gmail.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	VarseoSmile TriniQ
Regulation Name:	Material, Tooth Shade, Resin
Regulation Number:	21 CFR 872.3690
Device Class:	Class II
Product Code:	EBF
Secondary Product Code:	EBG, PZY
Review Panel:	Dental
Reviewing Branch:	Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
	Dental Devices (DHT1B)

PREDICATE DEVICE INFORMATION

The Subject device in this submission is substantially equivalent in indications, use and design principles to the following Predicate device.

510(k)	Predicate Device Name	Company Name
K213343	saremco print CROWNTEC	Saremco Dental AG
510(k)	Reference Device Name	Company Name
K201668	VarseoSmile CrownPlus	BEGO Bremer Goldschlägerei Wilh.

INDICATIONS FOR USE

VarseoSmile TriniQ is indicated as an indirect restorative for both anterior restorations, including occlusal surfaces. The VarseoSmile TriniQ material is used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and bridge restorations. VarseoSmile TriniQ can also be used for the fabrication of artificial teeth and temporary crowns & bridges.

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DEVICE DESCRIPTION

Restorations fabricated using the Subject device are one-time use, prescription-only devices.

Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration. Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical, and biocompatible properties.

The Subject device is intended to be sold by the bottle and used with compatible hardware in computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.

EQUIVALENCE TO MARKETED DEVICE

The Subject device is highly similar to the Predicate device with respect to Indications for Use and technological principles. The comparison tables below compare the Indications for Use and Technological Characteristics of the Subject, Predicate and Reference devices.

Indications For Use

Device	Indications for Use Statement
Subject DeviceVarseoSmile TriniQBEGO Bremer Goldschlägerei Wilh. HerbstGmbH & Co. KG	VarseoSmile TriniQ is indicated as an indirect restorative for both anterior and posteriorrestorations, including occlusal surfaces. The VarseoSmile TriniQ material is used for fabricatingpermanent restorations such as inlays, onlays, veneers, full crown and bridge restorations.VarseoSmile TriniQ can also be used for the fabrication of artificial teeth and temporary crowns &bridges.
Predicate Devicesaremco print CROWNTEC (K213343)Saremco Dental AG	saremco print CROWNTEC is a light-curing 3D-printed material intended as an indirect restorativefor both anterior and posterior restorations, including occlusal surfaces. The saremco printCROWNTEC material is used for fabricating permanent restorations such as inlays, onlays, veneersand full crown restorations. saremco print CROWNTEC can also be used for the fabrication ofartificial teeth and temporary crowns & bridges.
Reference DeviceVarseoSmile Crown Plus (K201668)BEGO Bremer Goldschlägerei Wilh. HerbstGmbH & Co. KG	VarseoSmile Crown Plus is indicated as an indirect restorative for both anterior and posteriorrestorations, including occlusal surfaces. The VarseoSmile Crown Plus material is used for fabricatingpermanent restorations such as inlays, onlays, veneers and full crown restorations.

The Subject and Predicate Indications for Use Statement (IFUS) are highly similar, differing only in the device name. The Reference device IFUS is similar in wording, with a similar usage of the material, but focusing only on permanent restorations. Slight differences in the wording of the device name within Indications for Use Statements does not change the intended use of the Subject and Predicate devices to fabricate temporary or permanent dental restorations.

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Technological Characteristics

Parameter	Subject DeviceVarseoSmile TriniQ	Predicate Devicesaremco print CROWNTEC (K213343)	Reference DeviceVarseoSmile Crown Plus (K201668)	Comparison withPredicate Device
	BEGO Bremer Goldschlägerei Wilh.Herbst GmbH & Co. KG	Saremco Dental AG	BEGO Bremer Goldschlägerei Wilh.Herbst GmbH & Co. KG
Reason forPredicate/Reference	n/a	IFUS, Usage	Biocompatibility	Same
Product Code	EBF, EBG, PZY	EBF, EBG, PZY	EBF	Same
Regulation Number	872.3690	872.3690	872.3690	Same
Regulatory Class	Class II	Class II	Class II	Same
Intended Use	A methacrylate-based material for3D printing (extra-oral light curing)of dental restorations.	saremco print CROWNTEC is amethacrylate-based material for3D printing of dental restorations.	An indirect methacrylate-basedrestorative material used inconjunction with extra-oral lightcuring equipment for both anteriorand posterior restorations, includingocclusal surfaces. It is intended to beused for fabricating permanentrestorations such as inlays, onlays,veneers and full crown restorations.	Highly Similar
Technology	3D liquid (light-cured) print resin fordental CAD/CAM	3D liquid (light-cured) print resinfor dental CAD/CAM	3D liquid (light-cured) print resin fordental CAD/CAM	Same
Material Type	Methacrylate-based polymer resin	Methacrylate-based polymer resin	Methacrylate-based polymer resin	Same
Material Shades	Common VITA-shades	Common VITA-shades	Common VITA-shades	Same
Biocompatible	Yes	Yes	Yes	Same
OTC or Rx	Rx	Rx	Rx	Same
Sterile	Non-sterile	Non-sterile	Non-sterile	Same
ChemicalComposition	Methacrylate-based resins, dentalglass filler, photo initiators andpigments.	Methacrylate-based resins, dentalglass filler, photo initiators andpigments.	Methacrylate-based resins, dentalglass filler, photo initiators andpigments.	Same
Polymerization	UV light, 385 or 405 nm	UV light, 385 or 405 nm	UV light, 385 or 405 nm	Same
(Curing) MethodEquipment	w/post curingValidated 3D-Printer and post curingdevices	w/post curingValidated 3D-Printer and postcuring devices	w/post curingValidated 3D-Printer and post curingdevices	Same
Performance Testing	ISO 4049:2019ISO 10477:2020ISO 22112:2017	ISO 4049:2019ISO 10477:2020ISO 22112:2017	ISO 4049:2013ISO 10477:2018	Same
Flexural Strength	≥ 100 MPa	≥ 100 MPa	≥ 100 MPa	Same
Biocompatibility	ISO 10993-1:2018ISO 10993-5:2009ISO 10993-10:2021ISO 10993-17:2002ISO 10993-18:2020ISO 10993-23:2021	ISO 7405:2018ISO 10993-1:2018	ISO 10993-1:2018	Similar

The Technological Characteristics of the Subject and Predicate devices are the Same, Similar or Highly Similar.

Product Code/Regulation Number/Regulatory Class - The Subject and Predicate devices are the same.

Intended Use - The Subject and Predicate devices are Highly Similar in their intended use, differing only in reference to the device name. The Subject and Reference devices are Similar in their intended use, with the wording of the Subject device simplified to be inclusive of both permanent and temporary dental restorations through a general reference of "dental restorations".

Material/Chemical Composition - The Subject, Predicate and Reference devices are Same as they are all methacrylate-based polymer resins. Slight differences in chemical composition do not change the intended use of the Subject and Predicate devices to be used in the fabrication of dental restorations. The Subject device has demonstrated suitability for intended use through material non-clinical performance testing.

Rx/Sterility/Shades – The Subject, Predicate and Reference devices are the same.

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Polymerization (Curing) Method - The Subject and Predicate devices are the Same. The Subject and Reference devices are the Same.

Equipment – The Subject, Predicate and Reference devices are they have all been validated to work with compatible 3D printers and post-curing equipment.

Flexural Strength – The Subject, Predicate and Reference devices are the same with measured Flexural Strength values in excess of 100 MPa.

Performance Testing - The Subject and Predicate devices were tested to and met the requirements of the same material performance standards.

Biocompatibility - The Subject and Predicate devices are similar in the standards and biological endpoints the devices were evaluated to. Slight differences in the standards and tested endpoints do not change the intended use of the Subject and Predicate devices. Biocompatibility of the sponsor's Reference device is leveraged for the Subject device. Confirmatory cytotoxicity testing to ISO 10993-5, sensitization testing to ISO 10993-10, and irritation testing to ISO 10993-23 was performed on the Subject device.

Technological differences between the Subject and Predicate devices have been evaluated through non-clinical performance testing. The results of the tests performed show that the Subject device meets the requirements mentioned in the applicable standards and confirm that the Subject device performs similarly to Predicate device.

CLINICAL AND ANIMAL TESTING

The performance of methacrylate-based polymer resins in the clinical environment has been well established. No clinical or animal testing data is included in this submission.

NON-CLINICAL PERFORMANCE TESTING

Validation of the manufacturing process and compatible equipment was performed demonstrating consistency of the process output with that of the process input.

Physical property testing was performed on the Subject device to ISO 4049:2019, Dentistry — Polymer-based restorative materials, ISO 10477:2020, Dentistry – Polymer-based crown and veneering materials. Confirmatory testing was performed to ISO 22112:2017, Dentistry – Artificial teeth for dental prostheses. In most cases, results demonstrated the Subject device meets the property requirements of the referenced standards. Where performance test results did not meet the standard requirements, comparative testing was performed with the K201668 Reference device to support substantial equivalence.

A biological evaluation was performed on the Subject device according to ISO 10993-1. Biocompatibility testing was leveraged from the sponsor's K201668 Reference device. A comparative chemical characterization and toxicological assessment with the K201668 Reference device was performed to ISO 10993-18 with a risk assessment performed according to ISO 10993-17 and ISO/TS 21726. Confirmatory cytotoxicity testing was performed on the Subject device according to ISO 10993-5:2009.

An MRI safety assessment was performed on the Subject device to support MR Safety labeling as required by the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".

Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above. This non-clinical performance testing demonstrates that the Subject device is suitable for intended use.

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CONCLUSION

Overall, the Indications for Use statements for the Subject and Predicate devices are the same differing only in device name and slightly in use duration. Overall, the Technological Characteristics of the Subject device are the same or highly similar to the Predicate device with any differences mitigated through non-clinical performance testing.

Overall, these similarities between the Subject and Predicate devices support a determination of substantial equivalence.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.