(1 days)
No
The device description focuses on the material properties and manufacturing process of a 3D printable resin for dental restorations. There is no mention of AI or ML in the intended use, device description, or performance studies. The design process is described as using standard dental CAD software, which is not typically considered AI/ML.
No.
This device is a material for fabricating dental restorations, such as crowns and bridges, which replace or restore the function of missing or damaged teeth. While these restorations can improve oral health and function, the device itself is not directly therapeutic in the sense of treating or curing a disease or medical condition.
No
Explanation: The device is a resin used in 3D printing to create permanent or temporary dental restorations like crowns, bridges, and veneers. It is a manufacturing material for prosthetics, not a device used to diagnose medical conditions.
No
The device description clearly states the subject device is a "light-cured methacrylate-based resin used in 3D printers" and is "intended to be sold by the bottle". This indicates it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fabricating permanent and temporary dental restorations (inlays, veneers, crowns, bridges, artificial teeth). This is a direct application to the patient's body for structural and aesthetic purposes.
- Device Description: The device is a resin used in 3D printing to create physical dental prosthetics. It's a material used in a manufacturing process for a medical device that will be placed in the mouth.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It doesn't analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used to create a medical device that is then used in vivo (in the body).
N/A
Intended Use / 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, veneers, full crown and bridge restorations. VarseoSmile TriniQ can also be used for the fabrication of artificial teeth and temporary crowns & bridges.
Product codes (comma separated list FDA assigned to the subject device)
EBF, EBG, PZY
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.
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 technician
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)
Physical property testing:
- Study type: Performance testing
- Sample size: Not specified
- Key results: Tested 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.
Biocompatibility:
- Study type: Biological evaluation
- Sample size: Not specified
- Key results: Performed 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. Sensitization testing to ISO 10993-10, and irritation testing to ISO 10993-23 was performed on the Subject device.
MRI Safety:
- Study type: MRI safety assessment
- Sample size: Not specified
- Key results: 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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength: ≥ 100 MPa
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
§ 872.3690 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out to the right of the square.
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.
1
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
2
Indications for Use
510(k) Number (if known)
Device Name VarseoSmile TriniQ
Indications for Use (Describe)
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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Consultant: | |
|---|---|---|
| BEGO Bremer Goldschlägerei Wilh. | ||
| Herbst GmbH & Co. KG | ||
| Wilhelm-Herbst-Straße 1 | ||
| 28359 Bremen, Germany | ||
| Telephone: +49 421 2028-157 | Aclivi, LLC | |
| 3250 Brackley Drive | ||
| Ann Arbor, Michigan 48105 | ||
| Telephone: +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 Crown | |
| Plus | 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.
4
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.
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 Device | |
| VarseoSmile TriniQ | |
| BEGO Bremer Goldschlägerei Wilh. Herbst | |
| GmbH & Co. KG | VarseoSmile TriniQ is indicated as an indirect restorative for both anterior and posterior |
| 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. | |
| Predicate Device | |
| saremco print CROWNTEC (K213343) | |
| Saremco Dental AG | saremco print CROWNTEC is a light-curing 3D-printed material intended as an indirect restorative |
| for both anterior and posterior restorations, including occlusal surfaces. The saremco print | |
| CROWNTEC material is used for fabricating permanent restorations such as inlays, onlays, veneers | |
| and full crown restorations. saremco print CROWNTEC can also be used for the fabrication of | |
| artificial teeth and temporary crowns & bridges. | |
| Reference Device | |
| VarseoSmile Crown Plus (K201668) | |
| BEGO Bremer Goldschlägerei Wilh. Herbst | |
| GmbH & Co. KG | VarseoSmile Crown Plus is indicated as an indirect restorative for both anterior and posterior |
| restorations, including occlusal surfaces. The VarseoSmile Crown Plus material is used for fabricating | |
| permanent 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.
5
Technological Characteristics
| Parameter | Subject Device
VarseoSmile TriniQ | Predicate Device
saremco print CROWNTEC (K213343) | Reference Device
VarseoSmile Crown Plus (K201668) | Comparison with
Predicate Device |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| | BEGO Bremer Goldschlägerei Wilh.
Herbst GmbH & Co. KG | Saremco Dental AG | BEGO Bremer Goldschlägerei Wilh.
Herbst GmbH & Co. KG | |
| Reason for
Predicate/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 for
3D printing (extra-oral light curing)
of dental restorations. | saremco print CROWNTEC is a
methacrylate-based material for
3D printing of dental restorations. | An indirect methacrylate-based
restorative material used in
conjunction with extra-oral light
curing equipment for both anterior
and posterior restorations, including
occlusal surfaces. It is intended to be
used for fabricating permanent
restorations such as inlays, onlays,
veneers and full crown restorations. | Highly Similar |
| Technology | 3D liquid (light-cured) print resin for
dental CAD/CAM | 3D liquid (light-cured) print resin
for dental CAD/CAM | 3D liquid (light-cured) print resin for
dental 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 |
| Chemical
Composition | Methacrylate-based resins, dental
glass filler, photo initiators and
pigments. | Methacrylate-based resins, dental
glass filler, photo initiators and
pigments. | Methacrylate-based resins, dental
glass filler, photo initiators and
pigments. | Same |
| Polymerization | UV light, 385 or 405 nm | UV light, 385 or 405 nm | UV light, 385 or 405 nm | Same |
| (Curing) Method
Equipment | w/post curing
Validated 3D-Printer and post curing
devices | w/post curing
Validated 3D-Printer and post
curing devices | w/post curing
Validated 3D-Printer and post curing
devices | Same |
| Performance Testing | ISO 4049:2019
ISO 10477:2020
ISO 22112:2017 | ISO 4049:2019
ISO 10477:2020
ISO 22112:2017 | ISO 4049:2013
ISO 10477:2018 | Same |
| Flexural Strength | ≥ 100 MPa | ≥ 100 MPa | ≥ 100 MPa | Same |
| Biocompatibility | ISO 10993-1:2018
ISO 10993-5:2009
ISO 10993-10:2021
ISO 10993-17:2002
ISO 10993-18:2020
ISO 10993-23:2021 | ISO 7405:2018
ISO 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.
6
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.
7
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.