(198 days)
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.
Light-Cure Resin, provided in a container.
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.
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:
Printer: Brand: 3D Systems, Type: NextDent 5100 Figure 4, Software: 3D Sprint
Post-cure unit: Brand: NextDent, Type: LC-3DPrint Box, Software: 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.
The provided text is a 510(k) summary for a dental resin product, NextDent Ortho Flex, and primarily discusses its substantial equivalence to a predicate device based on material characteristics and performance in specific laboratory tests. It does not contain information related to an AI/ML-enabled medical device, diagnostic performance, or studies involving human readers or ground truth established by experts/pathology/outcomes data.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance in the context of an AI/ML device. The document focuses on the physical and chemical properties of a 3D printable dental resin.
To illustrate, here's what the document does discuss regarding "acceptance criteria" and "study" for NextDent Ortho Flex, which is very different from an AI/ML device:
Acceptance Criteria and Study for NextDent Ortho Flex (Dental Resin)
The "acceptance criteria" for this device are based on its compliance with established industry standards for dental materials, specifically ISO 20795-2:2013 and ISO 10993 series for biocompatibility. The "study" involves a series of bench tests to verify these properties.
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table with specific numerical acceptance criteria and corresponding reported values. Instead, it states compliance with standards.
| Acceptance Criteria (Standard / Property) | Reported Device Performance |
|---|---|
| Material Properties: | |
| ISO 20795-2:2013 Dentistry – Base polymers - Part 2: Orthodontic base polymers (Type 2 light-activated material) | "NextDent Ortho Flex is compliant to the applicable requirements defined in ISO 20795-2:2013 for Type 2 light-activated material." |
| Curing | Tested and deemed compliant |
| Color | Tested and deemed compliant |
| Porosity | Tested and deemed compliant |
| Ultimate flexural strength | Tested and deemed compliant |
| Flexural modulus | Tested and deemed compliant |
| Maximum stress intensity factor | Tested and deemed compliant |
| Fracture work | Tested and deemed compliant |
| Charpy impact strength | Tested and deemed compliant |
| Sorption | Tested and deemed compliant |
| Solubility | Tested and deemed compliant |
| Biocompatibility: | |
| ISO 10993-1:2018 (Surface device, not in contact with oral mucosa / mucosal membrane, permanent (>30 days), repeated use) | "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." |
| Biocompatibility tests (Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity, Subacute/sub chronic systemic toxicity, Genotoxicity) | Deemed compliant to applicable requirements. |
| Shelf-Life: | |
| Stability for 18 months | "NextDent Ortho Flex has a shelf life of 18 months." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the bench tests (e.g., how many specimens for flexural strength). It also does not mention data provenance in terms of country of origin or whether the data was retrospective or prospective, as this is typically irrelevant for material property bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth as typically understood for AI/ML devices (e.g., expert consensus on image interpretation, pathology reports) is not relevant for the bench testing of a dental resin's physical and chemical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no expert review or adjudication process described, as the tests are objective laboratory measurements against predefined standards.
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
Not applicable. This device is a material for manufacturing dental products, not an AI/ML diagnostic tool. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As above, this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is compliance with established international standards for dental materials (e.g., ISO 20795-2:2013 for mechanical properties and the ISO 10993 series for biocompatibility) as demonstrated through objective laboratory testing.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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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
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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
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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) |
|---|---|
| -------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
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Section 5.0
K221022
510(k) SUMMARY— NextDent Ortho Flex
| I. SUBMITTER | |
|---|---|
| Submitter Name: | Vertex-Dental B.V. |
| Submitter Address: | Centurionbaan 1903769 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 |
| ClassificationRegulation | N.a. | 21 CFR 872.5525 |
| III. PREDICATEDEVICE(s) | Nightguard Flex, K212448 (Primary predicate) |
|---|---|
| ----------------------------- | ---------------------------------------------- |
| IV. DEVICEDESCRIPTION | |
|---|---|
| Device Identification: | Light-Cure Resin, provided in a container. |
| Device Characteristics: | NextDent Ortho Flex is a dimethacrylic based light-cureresin with pigments, polymerized via photo initiators in a 3Dprinter setting for fabrication of splints and retainers for longterm repeated use. |
| Environment of Use: | Healthcare facility/hospital Dental (technical) laboratory. |
| Summary (Description)of Device: | Fabrication of splints and retainers with NextDent OrthoFlex requires a computer-aided and manufacturing(CAD/CAM) system that includes the following additiveprinter and post-cure unit: |
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| 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 FORUSE | 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. TECHNOLOGICALCHARACTERISTICS | 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. COMPARISONTO THE PREDICATEDEVICE: | |
|---|---|
| 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. |
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| TECHNOLOGICALCHARACTERISTICS: | 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 | ||||||
|---|---|---|---|---|---|---|---|
| Technologicalcharacteristics | Predicate deviceNightGuard Flex* | New device:NextDent Ortho Flex | |||||
| Brand | Type | Brand | Type | Software | |||
| Design: | Printer | SprintRay | Pro Printer | 3D Systems | NextDent 5100Figure 4® | 3D Sprint | |
| Post-Curing: | Post-cure unit | SprintRay | ProCure | NextDent™ | LC-3DPrint Box | n.a. | |
| VIII. SUMMARY OFTESTING[PERFORMANCEDATA] | 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. | ||||||
| BiocompatibilityTesting: | 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. |
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| Bench Testing | NextDent Ortho Flex is tested for conformity with theindustry standard ISO 20795-2:2013 Dentistry - Basepolymers - Part 2: Orthodontic base polymers.NextDent Ortho Flex is compliant to the applicablerequirements defined in ISO 20795-2:2013 for Type 2 light-activated material.The following bench tests are conducted on NextDent OrthoFlex:• Curing• Color• Porosity• Ultimate flexural strength• Flexural modulus• Maximum stress intensity factor• Fracture work• Charpy impact strength• Sorption• SolubilityThere is no influence to be expected of re-use, printorientation and print placement on the finaldevice for NextDent Ortho Flex when printed on theNextDent5100 3Dprinter.Difference between printer, difference between design, lowand high temperature and or humidity are meeting therequirements of the final device made from NextDent OrthoFlex on the NextDent5100 3Dprinter. |
|---|---|
| Reprocessing, Sterilityand Shelf-Life Testing | The device is provided non-sterile.From the Shelf life testing, NextDent Ortho Flex has a shelflife of 18 months. |
| IX. CONCLUSIONS | NextDent Ortho Flex and the predicate have the sameintended use and similar technological characteristics.The results of the performed tests show that NextDent OrthoFlex meets the applicable requirements mentioned in theapplicable standards and confirm that the device performssimilarly to the predicate device.It is therefore concluded that NextDent Ortho Flex performsas intended and is substantially equivalent to the predicatedevice. |
N/A