(138 days)
Not Found
No
The summary describes a 3D printing resin and the manufacturing process, with no mention of AI or ML in the intended use, device description, or performance studies.
No.
The devices are resins used to print denture bases, artificial teeth, temporary crowns, or bridges, which are restorative tools, not therapeutic devices intended to treat or cure a disease or medical condition.
No
Explanation: The device is a light-curing resin used for 3D printing of denture bases and artificial teeth. Its intended use is to fabricate dental prosthetics, which is a treatment or restorative function, not a diagnostic one.
No
The device description clearly states that the device is a light curing resin intended for 3D printing, which is a physical material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the 3D printing of denture bases and artificial teeth to form dentures, temporary crowns, or bridges. These are physical devices used in the mouth for structural and functional purposes.
- Device Description: The description details the composition of the resins and the 3D printing process to create physical dental prosthetics.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on biological samples to gain information about a patient's health status. This device is used to create a physical product that is placed in the patient's mouth.
N/A
Intended Use / Indications for Use
NextDent Jet Denture Base is a light curing resin intended for 3D printing of a full or partial denture base to form a denture. The product, when used in combination with NextDent Jet Denture Teeth can be used for 3D printing a removable full or partial denture. For dental professional use only.
NextDent Jet Denture Teeth is a light curing resin intended for the 3D printing of artificial teeth to form a denture, temporary crowns or bridges. The product, when used in combination with NextDent Jet Denture Base can be used for 3D printing a removeable full or partial denture. For dental professional use only.
Product codes
EBI, EBG, PZY
Device Description
Light-Curable Resin
NextDent Jet Denture resins are pre-mixed combinations of acrylate-based light-cure resins with pigments, polymerized via photo initiators in a 3D printer setting for the fabrication of full or partial denture bases and artificial teeth to form a denture and for the fabrication of temporary crowns or bridges.
The resins must be used in combination with 3D Systems printers that support MultiJet Printing technology. Printer Brand Software Projet MJP 5600 3D Systems 3D Sprint Fit of the parts strongly depends on design and library used. Please take features like undercuts and spacers in consideration when designing the parts. Devices are produced in an automated additive manufacturing method where ultra-thin layers of photopolymer material are jetted onto a build tray. Immediately after being jetted, each photopolymer layer is cured by UV light. The process repeats layer by layer until the 3D part is complete. Upon completion the support material is removed, and the product is cleaned. When printing a denture base, bonding of artificial teeth to the denture base is possible to form a denture. The bonding agent instructions should be followed. Printed parts are finished using conventional dental methods and instruments.
Combination of acrylate-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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professional use only
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 Jet Denture resins are tested for mechanical characteristics as part of the product specifications. The most applicable standard for mechanical characteristics determination for denture bases is ISO 20795-1:2013 Dentistry - Base polymers - Part 1 Denture base polymers and for crown and bridges ISO 10477:2020 Dentistry. Polymer-based crown and veneering materials.
Biocompatibility Testing:
According to both ISO 7405:2018 and ISO 10993-1: 2018 NextDent Jet Denture resins are considered a surface device, in contact with intact mucosal membrane, permanent (> 30 days), repeated use. NextDent Jet Denture resins are compliant to the applicable requirements defined in ISO 10993 including parts 1, 3, 5, 10, 12, 17, 18 and 23, ISO 7405 and ISO/TS 21726 for permanent medical devices and therefore biocompatible.
Bench Testing:
NextDent Jet Denture Base is tested according to the relevant methods in the standard ISO 20795-1:2013 Dentistry - Base polymers – Part 1 Denture base polymers. NextDent Jet Denture Base is compliant to the requirements defined in ISO 20795-1:2013 for Type 4 light activated material except for ultimate flexural strength, flexural modulus, water sorption and solubility. Improved impact resistance is not claimed for the device.
The following bench tests are conducted on NextDent Jet Denture Base:
• Surface characteristics
• Polishability
• Color
• Color stability
• Translucency
• Freedom from porosity
• Ultimate flexural strength
• Flexural modulus
• Maximum stress intensity factor
• Total fracture work Bonding to synthetic polymer teeth (ISO 22112) Sorption and Solubility Dynamic Fatigue testing Charpy impact strength (ISO 179-1)
NextDent Jet Denture Teeth is tested according to the relevant methods and meets the relevant requirements in ISO 10477 for Type 2, Class 2: polymer-based crown and veneering materials that contain a photo-polymerization initiator.
The following bench tests are conducted on NextDent Jet Denture Teeth:
Flexural strength Water sorption Sorption and Solubility Color stability Shade consistency Surface characteristics Polishability
The mechanical performance of NextDent Jet Denture resins printed on the Projet MJP 5600 printer is verified confirming its sufficient repeatability and robustness regarding print orientation and placement.
Reprocessing, Sterility and Shelf-Life Testing:
The device is provided non-sterile. NextDent Jet Denture resins have a shelf life of two years.
Conclusions:
NextDent Jet Denture resins and the predicate devices have similar intended use and technological characteristics. The results of the performed tests show that: NextDent Jet Denture Base meets the applicable requirements of ISO 20795-1:2013 Dentistry – Base polymers - Part 1 Denture base polymers and confirm that the device performs similarly to the primary predicate device. NextDent Jet Denture Teeth meets the relevant requirements of ISO 10477:2020 Dentistry. Polymer-based crown and veneering materials and performs similarly to the secondary predicate device. It is therefore concluded that NextDent Jet Denture resins perform as intended and are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(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 logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The text reads "U.S. FOOD & DRUG ADMINISTRATION".
September 4, 2024
Vertex-Dental B.V. Bart Romanus Director Regulatory Affairs Centurionbaan 190 Soesterberg, 3769AV Netherlands
Re: K241071
Trade/Device Name: NextDent Jet Denture Base; NextDent Jet Denture Teeth Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI, EBG, PZY Dated: April 19, 2024 Received: April 19, 2024
Dear Bart Romanus:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
NextDent Jet Denture Base; NextDent Jet Denture Teeth
Indications for Use (Describe)
NextDent Jet Denture Base is a light curing resin intended for 3D printing of a full or partial denture base to form a denture. The product, when used in combination with NextDent Jet Denture Teeth can be used for 3D printing a removable full or partial denture. For dental professional use only.
NextDent Jet Denture Teeth is a light curing resin intended for the 3D printing of artificial teeth to form a denture, temporary crowns or bridges. The product, when used in combination with NextDent Jet Denture Base can be used for 3D printing a removeable full or partial denture. For dental professional use only.
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.
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"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."
4
510(k) SUMMARY– NextDent Jet Denture - K241071
| I. SUBMITTER | |
|---|---|
| Submitter Name: | Vertex-Dental B.V. |
| Submitter Address: | Centurionbaan 190 |
| 3769 AV, Soesterberg, The Netherlands | |
| Contact Person: | |
| Telephone #: | B. Romanus |
| +32 470 18 84 22 | |
| Date: | April 19th, 2024 |
| II. DEVICE | |
|---|---|
| Device Trade Name: | NextDent Jet Denture Base, NextDent Jet Denture Teeth |
| Classification Name | Resin, denture, relining, repairing, rebasing |
| Crown and Bridge, Temporary, Resin; | |
| Additively Manufactured, Preformed, Resin Denture Tooth | |
| Product Codes | EBI, EBG, PZY |
| Regulatory Class | Class 2 |
| Classification Regulation | 21 CFR 872.3760 |
| 21 CFR 872.3770 | |
| 21 CFR 872.3590 |
| III. PREDICATE
DEVICE(s) | NextDent Base, K231388
Saremco Print CROWNTEC, K213343 |
| ----------------------------- | ----------------------------------------------------------- |
|---|
| IV. DEVICE
| DESCRIPTION | |||||||
|---|---|---|---|---|---|---|---|
| Device Identification: | Light-Curable Resin | ||||||
| Device Characteristics: | NextDent Jet Denture resins are pre-mixed combinations of | ||||||
| acrylate-based light-cure resins with pigments, polymerized | |||||||
| via photo initiators in a 3D printer setting for the fabrication | |||||||
| of full or partial denture bases and artificial teeth to form a | |||||||
| denture and for the fabrication of temporary crowns or | |||||||
| bridges. | |||||||
| Environment of Use: | Dental professional use only | ||||||
| Summary (Description) | |||||||
| of Device: | The resins must be used in combination with 3D Systems | ||||||
| printers that support MultiJet Printing technology. | |||||||
| Printer Brand Software Projet MJP 5600 3D Systems 3D Sprint Fit of the parts strongly depends on design and library used. | |||||||
| Please take features like undercuts and spacers in | |||||||
| consideration when designing the parts. |
5
| | Devices are produced in an automated additive
manufacturing method where ultra-thin layers of
photopolymer material are jetted onto a build tray.
Immediately after being jetted, each photopolymer layer is
cured by UV light. The process repeats layer by layer until
the 3D part is complete. Upon completion the support
material is removed, and the product is cleaned.
When printing a denture base, bonding of artificial teeth to
the denture base is possible to form a denture. The bonding
agent instructions should be followed.
Printed parts are finished using conventional dental
methods and instruments. |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials of Use: | Combination of acrylate-based resins with photo initiator
and pigments |
| V. INTENDED USE /
INDICATIONS FOR
USE | NextDent Jet Denture is a family of acrylic monomer resins
used for the fabrication of dental appliances such as
removable full and partial dentures, denture bases, artificial
teeth, temporary crowns, or bridges. |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NextDent Jet Denture Base is a light curing resin intended
for 3D printing of a full or partial denture base to form a
denture. The product, when used in combination with
NextDent Jet Denture Teeth can be used for 3D printing a
removable full or partial denture. |
| | NextDent Jet Denture Teeth is a light curing resin intended
for the 3D printing of artificial teeth to form a denture,
temporary crowns or bridges. The product, when used in
combination with NextDent Jet Denture Base can be used
for 3D printing a removeable full or partial denture.
Both materials are for dental professional use only. |
| VI. TECHNOLOGICAL
CHARACTERISTICS | NextDent Jet Denture resins are a combination of acrylate-
based UV light curable resins with pigments and
polymerized via with photo initiators in an automated
additive manufacturing 3D printer setting. |
| -------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| VII. COMPARISON
TO THE PREDICATE
DEVICE: | Both NextDent Jet Denture Base and the primary predicate
device (K231388) are resins intended for the manufacturing
of 3D printed full and partial removable denture base to form
a denture. |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE: | Both NextDent Jet Denture Teeth and the secondary
predicate device (K213343) are resins intended for the
manufacturing of 3D printed artificial teeth to form a denture
and temporary crowns or bridges. All devices are intended
exclusively for professional dental work. |
6
| TECHNOLOGICAL | Both NextDent Jet Denture resins and the predicate devices |
|---|---|
| CHARACTERISTICS: | have the following similar characteristics: |
| Pre-mixed combination of acrylate-based resin with photo-initiator and pigments Polymerization by UV light Automated printing of resin with a 3D printer and software in multiple layers, each light-cured before adding next layer Printed parts are finished using conventional dental methods and instruments. | |
| VIII. SUMMARY OF | NextDent Jet Denture resins are tested for mechanical |
| TESTING | |
| [PERFORMANCE | characteristics as part of the product specifications. The |
| most applicable standard for mechanical characteristics | |
| DATA] | determination for denture bases is ISO 20795-1:2013 |
| Dentistry - Base polymers - Part 1 Denture base polymers | |
| and for crown and bridges ISO 10477:2020 Dentistry. | |
| Polymer-based crown and veneering materials. | |
| Biocompatibility | According to both ISO 7405:2018 and ISO 10993-1: 2018 |
| Testing: | NextDent Jet Denture resins are considered a surface |
| device, in contact with intact mucosal membrane, | |
| permanent (> 30 days), repeated use. | |
| NextDent Jet Denture resins are compliant to the applicable | |
| requirements defined in ISO 10993 including parts 1, 3, 5, | |
| 10, 12, 17, 18 and 23, ISO 7405 and ISO/TS 21726 for | |
| permanent medical devices and therefore biocompatible. |
| Bench Testing | NextDent Jet Denture Base is tested according to the
relevant methods in the standard ISO 20795-1:2013
Dentistry - Base polymers – Part 1 Denture base polymers. |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NextDent Jet Denture Base is compliant to the requirements
defined in ISO 20795-1:2013 for Type 4 light activated
material except for ultimate flexural strength, flexural
modulus, water sorption and solubility. Improved impact
resistance is not claimed for the device. |
| | The following bench tests are conducted on NextDent Jet
Denture Base: |
| | • Surface characteristics
• Polishability
• Color
• Color stability
• Translucency
• Freedom from porosity |
| | • Ultimate flexural strength
• Flexural modulus
• Maximum stress intensity factor |
7
| Total fracture work Bonding to synthetic polymer teeth (ISO 22112) Sorption and Solubility Dynamic Fatigue testing Charpy impact strength (ISO 179-1) | |
|---|---|
| NextDent Jet Denture Teeth is tested according to the | |
| relevant methods and meets the relevant requirements in | |
| ISO 10477 for Type 2, Class 2: polymer-based crown and | |
| veneering materials that contain a photo-polymerization | |
| initiator. | |
| The following bench tests are conducted on NextDent Jet | |
| Denture Teeth: | |
| Flexural strength Water sorption Sorption and Solubility Color stability Shade consistency Surface characteristics Polishability | |
| The mechanical performance of NextDent Jet Denture | |
| resins printed on the Projet MJP 5600 printer is verified | |
| confirming its sufficient repeatability and robustness | |
| regarding print orientation and placement. | |
| Reprocessing, Sterility | |
| and Shelf-Life Testing | The device is provided non-sterile. |
| NextDent Jet Denture resins have a shelf life of two years. | |
| IX. CONCLUSIONS | NextDent Jet Denture resins and the predicate devices have |
| similar intended use and technological characteristics. | |
| The results of the performed tests show that: | |
| NextDent Jet Denture Base meets the applicable | |
| requirements of ISO 20795-1:2013 Dentistry – Base | |
| polymers - Part 1 Denture base polymers and |
| confirm that the device performs similarly to the
primary predicate device.
NextDent Jet Denture Teeth meets the relevant
●
requirements of ISO 10477:2020 Dentistry.
Polymer-based crown and veneering materials and
performs similarly to the secondary predicate
| device. |
|---|
| It is therefore concluded that NextDent Jet Denture resins |
| perform as intended and are substantially equivalent to the |
| predicate devices. |
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