(161 days)
NextDent Denture 3D+, K191497
Not Found
No
The summary describes a light-cure resin for 3D printing denture bases and the associated performance and biocompatibility testing. There is no mention of AI, ML, image processing, or any other technology that would typically indicate the presence of AI/ML.
No
The device is a material used for the manufacturing of denture bases, which are prosthetic devices, not therapeutic devices. Therapeutic devices are typically used for treatment or diagnosis.
No
This device is a light-cure resin for manufacturing denture bases, which is a therapeutic purpose, not a diagnostic one. Its intended use is to "support artificial teeth to form full or partial removable dentures," and the performance studies focus on mechanical properties and biocompatibility, not detection or diagnosis of a condition.
No
The device description explicitly states it is a "Light-Cure Resin" and a "combination of acrylate-based light-cure resin with pigments," which are physical materials, not software. The 510(k) summary focuses on the material properties and performance of this resin.
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 denture bases to support artificial teeth. This is a structural component for a medical device (denture), not a test performed on a biological sample to provide diagnostic information.
- Device Description: The description details a light-cure resin used in a 3D printer to create a physical object (denture base). It doesn't involve analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Use in a laboratory setting for diagnostic purposes (beyond a dental lab for fabrication)
The testing described (bench testing, biocompatibility, shelf-life) is typical for a medical device that comes into contact with the body, but not specifically for an IVD.
N/A
Intended Use / Indications for Use
NextDent Base is for dental professional use only and intended for the manufacturing of denture bases to support artificial teeth to form full or partial removable dentures.
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
NextDent Base is a combination of acrylate-based light-cure resin with pigments, polymerized via photo initiators in a 3D printer setting for fabrication of denture bases to support artificial teeth to form full or partial removable dentures. Fabrication of denture bases with NextDent Base requires a VAT based 3D printer that supports NextDent resins. Printer and resin must be optimized to each other to get complete and precise printed parts. Both the NextDentTM 5100 Figure4® 3D printer and the post-curing lightbox NextDentTM LC-3DPrint Box make use of a UV light source to polymerize the NextDent Base resin. NextDentTM5100 Figure4® 3D printer or NextDentTM 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral mucosa
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional / 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 Base is tested for mechanical characteristics as part of the product specification. The most applicable standard for mechanical characteristics determination of denture bases is ISO 20795-1:2013 Dentistry - Base polymers - Part 1 Denture base polymers.
Biocompatibility Testing: According to both ISO 7405:2018 and ISO 10993-1: 2018 NextDent Base is considered a surface device, in contact with intact oral mucosa, permanent (> 30 days), repeated use. The ISO 10993-1:2018 standard, including parts 3, 5, 10, 12, 17, 18 and 23 was followed and the following applicable biological safety hazard endpoints were addressed:
• Chemical characterization
• Cytotoxicity
• Acute systemic toxicity
• Subacute/sub chronic toxicity
• Irritation or intracutaneous reactivity
• Sensitization
• Genotoxicity
In addition, the following risks were considered based on a risk assessment, taking into account the specific nature and duration of exposure to the device
• Material mediated pyrogenicity
• Chronic toxicity
• Presence of phthalates
In addition, ISO 10993-17 and -18 and ISO/TS 21726 were followed to identify and quantitate the extractables and/or leachables that may be released from the test article to NextDent Base is 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 Base is tested according to the methods in the industry standard ISO 20795-1:2013 Dentistry – Base polymers - Part 1 Denture base polymers. NextDent Base is compliant to the requirements defined in ISO 20795-2:2013 for Type 4 light activated material except for ultimate flexural strength, flexural modulus and water solubility. Comparative testing showed that elasticity and impact resistance properties are substantially equivalent to the predicate. NextDent Base is regarding water solubility compliant to requirements defined in ISO 20795-1:2013 for type 2 autopolymerizable materials. The following bench tests are conducted on NextDent Base: Surface characteristics Polishability Color Color stability Translucency Freedom from porosity Ultimate flexural strength Flexural modulus Charpy impact strength Bonding to synthetic polymer teeth Sorption Solubility Dynamic fatigue Fracture work. The mechanical performance of NextDent Base printed on the NextDent 5100 printer is verified confirming its sufficient repeatability and robustness regarding print orientation, placement, and resin reuse.
Reprocessing, Sterility and Shelf-Life Testing: The device is provided non-sterile. From the Shelf-life testing, NextDent Base has a shelf life of two years.
Key Results: The results of the performed tests show that NextDent 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 predicate device. It is therefore concluded that NextDent Base performs as intended and is substantially equivalent to the predicate device.
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.
NextDent Denture 3D+, K191497
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
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 20, 2023
Vertex-Dental B.V. % Patsy Trisler, Jd, Rac Consultant Oserve Group US Inc. 350 S. Main Street Doylestown, Pennsylvania 18901
Re: K231388
Trade/Device Name: NextDent Base Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: October 2, 2023 Received: October 2, 2023
Dear Patsy Trisler, Jd, Rac:
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
(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.
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).
Sincerely.
Bobak Shirmohammadi -5
For Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and
2
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
510(k) Number (if known)
Device Name NextDent Base
Indications for Use (Describe)
NextDent Base is for dental professional use only and intended for the manufacturing of denture bases to support artificial teeth to form full or partial removable dentures.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K231388 Section 5.0
510(k) SUMMARY— NextDent Base
| I. SUBMITTER | |
|---|---|
| Submitter Name: | Vertex-Dental B.V. |
| Submitter Address: | Centurionbaan 190 |
| 3769 AV Soesterberg The Netherlands | |
| Contact Person: | N.C. - Peterse – van der Koppel |
| Telephone #: | +31 88 61 60 430 |
| Date Prepared: | October 20, 2023 |
| II. DEVICE | |
|---|---|
| Device Trade Name: | NextDent Base |
| Common Name(s): | Resin, denture |
| Classification Name | Resin, denture, relining, repairing, rebasing |
| Product Codes | EBI |
| Regulatory Class | Class 2 |
| Classification | |
| Regulation | 21 CFR 872.3760 |
| III. PREDICATE | NextDent Denture 3D+, K191497 (Primary Predicate) |
|---|---|
| DEVICE(s) | |
| IV. DEVICE | |
| DESCRIPTION | |
| Device Identification: | Light-Cure Resin, provided in a container. |
| Device Characteristics: | NextDent Base is a combination of acrylate-based light-cure |
| resin with pigments, polymerized via photo initiators in a 3D | |
| printer setting for fabrication of denture bases to support | |
| artificial teeth to form full or partial removable dentures. | |
| Environment of Use: | Healthcare facility/hospital Dental (technical) laboratory. |
| Summary (Description) | |
| of Device: | Fabrication of denture bases with NextDent Base requires a |
| VAT based 3D printer that supports NextDent resins. | |
| Printer and resin must be optimized to each other to get | |
| complete and precise printed parts. |
5
| | 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. |
| Fit of the parts strongly depends on design and library used.
Features like undercuts and spacers should be taken in
consideration when designing the parts. | | | | |
| Both the NextDentTM 5100 Figure4® 3D printer and the
post-curing lightbox NextDentTM LC-3DPrint Box make use
of a UV light source to polymerize the NextDent Base resin. | | | | |
| NextDentTM5100 Figure4® 3D printer or NextDentTM 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: | A combination of acrylate-based resins with photo-initiator
and pigments. | | | |
| V. INTENDED USE /
INDICATIONS FOR
USE | NextDent Base is for dental professional use only and
intended for the manufacturing of denture bases to
support artificial teeth to form full or partial removable
dentures. | | | |
| VI. TECHNOLOGICAL
CHARACTERISTICS | NextDent Base 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 post-
cured in the UV light chamber. The cured parts are finished
using dental methods. | | | |
| VII. COMPARISON
TO THE PREDICATE
DEVICE: | Both NextDent Base and the predicate device are resins
intended for the manufacturing of 3D printed full and partial
removable denture bases. | | | |
| INTENDED USE: | Both devices are intended exclusively for professional
dental work. | | | |
| TECHNOLOGICAL
CHARACTERISTICS: | Both NextDent Base and the predicate device have the
following similar characteristics: | | | |
6
| | • Pre-mixed light-cure combination of acrylate-based
resin with photo-initiator
• Polymerization and post-curing by UV light
• Automated printing of resin with the same 3D printer
and software in multiple layers, each light-cured
before adding next layer, with post curing in lightchamber
• Finished by using dental methods | | | | | | |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|----------------------------------|------------------------------|---------------|-------------------------------|-----------|
| | Technological
characteristics | Predicate device | | New device:
NextDent Base | | | |
| | | Brand | Type | Software | Brand | Type | Software |
| | Design:
Printer | 3D
Systems | NextDent
5100
Figure
4® | 3D Sprint | 3D
Systems | NextDent
5100
Figure 4® | 3D Sprint |
| | Post-Curing: | | | | | | |
| | Post-cure
unit | NextDentTM | LC-
3DPrint
Box | n.a. | NextDentTM | LC-
3DPrint
Box | n.a. |
| VIII. SUMMARY OF
TESTING
[PERFORMANCE
DATA] | NextDent Base is tested for mechanical characteristics as
part of the product specification. The most applicable
standard for mechanical characteristics determination of
denture bases is ISO 20795-1:2013 Dentistry - Base
polymers - Part 1 Denture base polymers. | | | | | | |
| Biocompatibility
Testing: | According to both ISO 7405:2018 and ISO 10993-1: 2018
NextDent Base is considered a surface device, in contact
with intact oral mucosa, permanent (> 30 days), repeated
use.
The ISO 10993-1:2018 standard, including parts 3, 5, 10,
12, 17, 18 and 23 was followed and the following applicable
biological safety hazard endpoints were addressed:
• Chemical characterization
• Cytotoxicity
• Acute systemic toxicity
• Subacute/sub chronic toxicity
• Irritation or intracutaneous reactivity
• Sensitization
• Genotoxicity
In addition, the following risks were considered based on a
risk assessment, taking into account the specific nature and
duration of exposure to the device
• Material mediated pyrogenicity
• Chronic toxicity
• Presence of phthalates
In addition, ISO 10993-17 and -18 and ISO/TS 21726 were
followed to identify and quantitate the extractables and/or
leachables that may be released from the test article to | | | | | | |
7
| | NextDent Base is 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 Base is tested according to the methods in the
industry standard ISO 20795-1:2013 Dentistry – Base
polymers - Part 1 Denture base polymers. |
| | NextDent Base is compliant to the requirements defined in
ISO 20795-2:2013 for Type 4 light activated material except
for ultimate flexural strength, flexural modulus and water
solubility. Comparative testing showed that elasticity and
impact resistance properties are substantially equivalent to
the predicate. NextDent Base is regarding water solubility
compliant to requirements defined in ISO 20795-1:2013 for
type 2 autopolymerizable materials. The following bench
tests are conducted on NextDent Base:
Surface characteristics Polishability Color Color stability Translucency Freedom from porosity Ultimate flexural strength Flexural modulus Charpy impact strength Bonding to synthetic polymer teeth Sorption Solubility Dynamic fatigue Fracture work |
| | The mechanical performance of NextDent Base printed on
the NextDent 5100 printer is verified confirming its sufficient
repeatability and robustness regarding print orientation,
placement, and resin reuse. |
| Reprocessing, Sterility
and Shelf-Life Testing | The device is provided non-sterile.
From the Shelf-life testing, NextDent Base has a shelf life of
two years. |
| IX. CONCLUSIONS | NextDent Base and the predicate have the same intended
use and similar technological characteristics. |
|-----------------|---------------------------------------------------------------------------------------------------------------------|
| | The results of the performed tests show that NextDent Base
meets the applicable requirements of ISO 20795-1:2013 |
8
| Dentistry - Base polymers – Part 1 Denture base polymers
and confirm that the device performs similarly to the
| predicate device. |
|---|
| It is therefore concluded that NextDent Base performs as |
| intended and is substantially equivalent to the predicate |
| device. |