← Product Code MQC · K221022 # NextDent Ortho Flex (K221022) _Vertex-Dental B.V. · MQC · Oct 21, 2022 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K221022 ## Device Facts - **Applicant:** Vertex-Dental B.V. - **Product Code:** MQC - **Decision Date:** Oct 21, 2022 - **Decision:** SESE - **Submission Type:** Abbreviated - **Device Class:** Class U - **Review Panel:** DE ## Intended Use NextDent Ortho Flex is a 3D print resin intended for the manufacturing of 3D printed dental splints and retainers. To retain the regulated dentition. NextDent Ortho Flex is intended exclusively for professional dental work. ## Device Story NextDent Ortho Flex is a dimethacrylate-based light-cure resin used for 3D printing dental splints and retainers. The resin is processed via a CAD/CAM system using a 3D printer (e.g., NextDent 5100 Figure 4) and a UV light-curing unit (e.g., NextDent LC-3DPrint Box). The device is intended for professional dental laboratory use. The printer uses UV light to polymerize the resin in layers; cured parts are finished using conventional dental instruments. The device benefits patients by providing custom-fit, long-term dental appliances for retaining dentition. ## Clinical Evidence Bench testing only. The device was evaluated for mechanical properties per ISO 20795-2:2013 (flexural strength, modulus, fracture work, impact strength, sorption, solubility) and biocompatibility per ISO 10993-1:2018 (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity). Results confirm compliance with requirements for Type 2 light-activated orthodontic base polymers. ## Technological Characteristics Dimethacrylate-based resin with photo-initiators and pigments. Polymerization via UV light (3D printing and post-curing). Compliant with ISO 20795-2:2013 (orthodontic base polymers) and ISO 10993-1:2018 (biocompatibility). Non-sterile, 18-month shelf life. ## Predicate Devices - Nightguard Flex ([K212448](/device/K212448.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). 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October 21, 2022 Vertex-Dental BV % Patsy Trisler Consultant Oserve Group US Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250 Re: K221022 Trade/Device Name: NextDent Ortho Flex Regulatory Class: Unclassified Product Code: MQC, KMY Dated: July 22, 2022 Received: July 22, 2022 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 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 {1}------------------------------------------------ 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, For Michael E. Adiodha. 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) K221022 Device Name NextDent Ortho Flex Indications for Use (Describe) NextDent Ortho Flex is a 3D print resin intended for the manufacturing of 3D printed dental splints and retainers. To retain the regulated dentition. NextDent Ortho Flex is intended exclusively for professional dental work. | 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}------------------------------------------------ # Section 5.0 ## K221022 ### 510(k) SUMMARY— NextDent Ortho Flex | I. SUBMITTER | | |---------------------------------|----------------------------------------------------------| | Submitter Name: | Vertex-Dental B.V. | | Submitter Address: | Centurionbaan 190
3769 AV Soesterberg The Netherlands | | Contact Person:
Telephone #: | N.C. - Peterse – van der Koppel
+31 88 61 60 430 | | Date Prepared: | October 21, 2022 | | II. DEVICE | | | |------------------------------|-------------------------------|------------------------------| | Device Trade Name: | NextDent Ortho Flex | | | Common Name(s): | Splint, retainer | | | Classification Name | Mouthguard, prescription | Positioner, Tooth, Preformed | | Product Codes | MQC | KMY | | Regulatory Class | Unclassified (pre- amendment) | Class 1 | | Classification
Regulation | N.a. | 21 CFR 872.5525 | | III. PREDICATE
DEVICE(s) | Nightguard Flex, K212448 (Primary predicate) | |-----------------------------|----------------------------------------------| |-----------------------------|----------------------------------------------| | IV. DEVICE
DESCRIPTION | | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Identification: | Light-Cure Resin, provided in a container. | | Device Characteristics: | NextDent Ortho Flex is a dimethacrylic based light-cure
resin with pigments, polymerized via photo initiators in a 3D
printer setting for fabrication of splints and retainers for long
term repeated use. | | Environment of Use: | Healthcare facility/hospital Dental (technical) laboratory. | | Summary (Description)
of Device: | Fabrication of splints and retainers with NextDent Ortho
Flex requires a computer-aided and manufacturing
(CAD/CAM) system that includes the following additive
printer and post-cure unit: | {4}------------------------------------------------ | Printing | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------| | Printer | Brand | Type | Software | | | 3D Systems | NextDent 5100 Figure 4 | 3D Sprint | | Post-Curing | | | | | Post-cure unit | Brand | Type | Software | | | NextDent | LC-3DPrint Box | n.a. | | Printer and resin must be optimized to each other in order to get complete and precise printed parts. | | | | | Both the NextDent™5100 Figure4® 3D printer and the post-curing lightbox NextDent™ LC-3DPrint Box make use of a UV light source to polymerize the NextDent Ortho Flex resin. | | | | | NextDent™5100 Figure4® 3D printer or NextDent™ LC-3DPrint Box is not included with the device. | | | | | Cured parts are finished using conventional dental methods and instruments. NextDent 3D printed cured parts should be cleaned with nonchemical products. | | | | | Materials of Use: | dimethacrylate-based resins with photo-initiator and pigments. | | | | V. INTENDED USE /
INDICATIONS FOR
USE | NextDent Ortho Flex is a 3D print resin intended for the manufacturing of 3D printed dental splints and retainers. To retain the regulated dentition. | | | | | NextDent Ortho Flex is intended exclusively for professional dental work. | | | | VI. TECHNOLOGICAL
CHARACTERISTICS | NextDent Ortho Flex is a pre-mixed acrylate-based UV light-cure resin with pigments and polymerized via photo initiators in a 3D printer setting, Automated printing of the resin in multiple | | | layers, each light-cured before adding next layer, are postcured in the UV light chamber. The cured parts are finished using dental methods. | VII. COMPARISON
TO THE PREDICATE
DEVICE: | | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | INTENDED USE: | Both NextDent Ortho Flex and the predicate device are indicated to retain the regulated dentition.
Both devices are intended exclusively for professional dental work. | {5}------------------------------------------------ | TECHNOLOGICAL
CHARACTERISTICS: | Both NextDent Ortho Flex and the predicate device have the following similar characteristics:
Pre-mixed light-cure acrylate-based resin with photo-initiator Polymerization and post-curing by UV light Automated printing of resin in multiple layers, each light-cured before adding next layer, with post curing in light chamber Finished by using dental methods | | | | | | | |------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--------------------------------------|-------------|------------------------------------|----------------------------|-----------| | | Technological
characteristics | | Predicate device
NightGuard Flex* | | New device:
NextDent Ortho Flex | | | | | | | Brand | Type | Brand | Type | Software | | | Design: | Printer | SprintRay | Pro Printer | 3D Systems | NextDent 5100
Figure 4® | 3D Sprint | | | Post-Curing: | Post-cure unit | SprintRay | ProCure | NextDent™ | LC-3DPrint Box | n.a. | | VIII. SUMMARY OF
TESTING
[PERFORMANCE
DATA] | NextDent Ortho Flex is tested for mechanical characteristics as part of the product specification. The most applicable standard for mechanical characteristics determination of splints and retainers is ISO 20795-2:2013 Dentistry – Base polymers - Part 2: Orthodontic base polymers.
NextDent Ortho Flex complies to the product specifications. | | | | | | | | Biocompatibility
Testing: | According to ISO 7405:2018 NextDent Ortho Flex is considered a surface device, not in contact with oral mucosa, permanent (> 30 days), repeated use.
According to ISO 10993-1:2018 NextDent Ortho Flex is considered a surface device in contact with mucosal membrane, permanent (>30 days), repeated use.
The ISO 10993-1:2018 standard, including parts 3, 5, 10, 11, 12, 17 and 18 was followed and the following applicable biological safety aspects have been addressed:
Cytotoxicity Sensitization Irritation or intra cutaneous reactivity Subacute/sub chronic systemic toxicity Genotoxicity NextDent Ortho Flex is compliant to the applicable requirements defined in ISO 10993 including parts 1, 3, 5, 10, 11, 12, 17 and 18 and ISO/TS 21726 for permanent medical devices and therefore biocompatible. | | | | | | | {6}------------------------------------------------ | Bench Testing | NextDent Ortho Flex is tested for conformity with the
industry standard ISO 20795-2:2013 Dentistry - Base
polymers - Part 2: Orthodontic base polymers.
NextDent Ortho Flex is compliant to the applicable
requirements defined in ISO 20795-2:2013 for Type 2 light-
activated material.
The following bench tests are conducted on NextDent Ortho
Flex:
• Curing
• Color
• Porosity
• Ultimate flexural strength
• Flexural modulus
• Maximum stress intensity factor
• Fracture work
• Charpy impact strength
• Sorption
• Solubility
There is no influence to be expected of re-use, print
orientation and print placement on the final
device for NextDent Ortho Flex when printed on the
NextDent5100 3Dprinter.
Difference between printer, difference between design, low
and high temperature and or humidity are meeting the
requirements of the final device made from NextDent Ortho
Flex on the NextDent5100 3Dprinter. | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Reprocessing, Sterility
and Shelf-Life Testing | The device is provided non-sterile.
From the Shelf life testing, NextDent Ortho Flex has a shelf
life of 18 months. | | IX. CONCLUSIONS | NextDent Ortho Flex and the predicate have the same
intended use and similar technological characteristics.

The results of the performed tests show that NextDent Ortho
Flex meets the applicable requirements mentioned in the
applicable standards and confirm that the device performs
similarly to the predicate device.

It is therefore concluded that NextDent Ortho Flex performs
as intended and is substantially equivalent to the predicate
device. | --- **Source:** [https://fda.innolitics.com/device/K221022](https://fda.innolitics.com/device/K221022) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com