(198 days)
Not Found
No
The summary describes a 3D printing resin and the associated hardware (printer and post-cure unit) used to fabricate dental splints and retainers. There is no mention of AI or ML being used in the resin itself, the printing process control, or any analysis of the resulting printed parts. The software mentioned (3D Sprint) is standard CAD/CAM software for preparing models for 3D printing, not AI/ML software.
Yes.
This device, a 3D print resin, is intended for the manufacturing of dental splints and retainers, which are used to retain regulated dentition and thus serve a therapeutic purpose.
No
Explanation: NextDent Ortho Flex is a 3D printing resin used to manufacture dental splints and retainers. It is a material used in the creation of a medical device, not a device that diagnoses conditions.
No
The device is a 3D print resin, which is a physical material, not software. While it is used in a process that involves software (CAD/CAM system, 3D printer software), the device itself is a tangible substance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the manufacturing of dental splints and retainers to retain regulated dentition. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The device is a light-cure resin used to fabricate physical dental devices. It does not involve testing samples from the human body to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on mechanical characteristics, biocompatibility, and bench testing related to the physical properties and safety of the fabricated dental devices. These are not diagnostic performance metrics.
In summary, the NextDent Ortho Flex resin is a material used to create medical devices (dental splints and retainers) that are placed in the body for therapeutic purposes. It does not fit the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
MQC, KMY
Device Description
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: 3D Systems, NextDent 5100 Figure 4, 3D Sprint Software
Post-cure unit: NextDent, LC-3DPrint Box, n.a. Software
Both the NextDentTM5100 Figure4® 3D printer and the post-curing lightbox NextDentTM LC-3DPrint Box make use of a UV light source to polymerize the NextDent Ortho Flex resin.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentition
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional dental work. Healthcare facility/hospital Dental (technical) laboratory.
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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. |