(288 days)
NextDent™ Denture / E-Denture is a light-cured resin indication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The material is an alternative to traditional heat cured and auto polymerization resins. NextDent ™ Denture is intended exclusively for professional dental work. Fabrication of denture bases with NextDent ™ Denture / E-Denture requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer and post-cure unt.
NextDent™ Denture / E-Denture 3D-printing material is a light-cured resin indicated for the manufacturing of denture bases. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printing, the printed product is placed in a UV-light curing box for final polymerization.
This document describes the premarket notification (510(k)) for the NextDent™ Denture/E-Denture, a light-cured resin for manufacturing denture bases. The focus of the provided text is on demonstrating substantial equivalence to a predicate device, primarily through bench testing and biocompatibility assessments, rather than an AI/ML-driven diagnostic or assistive device study.
Therefore, many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, effect size of human reader improvement with AI, standalone algorithm performance, training set details) are not applicable to this type of medical device submission.
However, I can extract the relevant acceptance criteria and performance data related to the physical properties and biocompatibility of the material.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally defined by the relevant ISO standards, specifically ISO 20975-1 for "Dentistry - Base polymers - Part 1: Denture base polymers" for mechanical properties, and ISO 10993-1 for biocompatibility.
| Acceptance Criteria (Standard / Test) | Reported Device Performance (Result for NextDent™ Denture/E-Denture) |
|---|---|
| Mechanical Properties (ISO 20975-1) | Complies with requirements for Type 4 materials, except for water solubility. |
| Flexural strength | Tested and meets requirements. |
| Flexural modulus | Tested and meets requirements. |
| Water sorption | Tested and meets requirements. |
| Water solubility | Slightly exceeds requirement for Type 4 materials, but meets criteria for Type 2 materials. |
| Residual monomer | Tested and meets requirements. |
| Biocompatibility (ISO 10993-1) | All aspects addressed, device considered safe. |
| Cytotoxicity (ISO 10993-5) | Tested and meets requirements. |
| Sensitization (ISO 10993-10) | Tested and meets requirements. |
| Irritation or intracutaneous reactivity (ISO 10993-10) | Tested and meets requirements. |
| Subacute/subchronic systemic toxicity (ISO 10993-3) | Tested and meets requirements. |
| Genotoxicity (ISO 10993-3) | Tested and meets requirements. |
| Carcinogenicity Risk Assessment | Considered and addressed. |
| Reproductive/developmental/organ toxicity Risk Assessment | Considered and addressed. |
| Immunotoxicity Risk Assessment | Considered and addressed. |
| Presence of phthalates Risk Assessment | Considered and addressed. |
| Shelf-Life | 2 years |
| Compatibility with CAD/CAM Systems | Compatible with specific listed scanners, design software, printers, and post-cure units. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The exact sample sizes for each specific mechanical and biocompatibility test are not provided in this summary document. The document states that tests were "conducted on NextDent™ Denture / E-Denture using all the compatible CAD/CAM systems."
- Data Provenance: Not specified, but generally, such tests would be conducted in a controlled laboratory setting (likely within the manufacturer's R&D or QA facilities or by a certified testing lab). The summary does not indicate country of origin for actual data collection, or if it's retrospective or prospective, as these terms are usually more relevant for clinical studies than material verification testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission is for a material (resin) used in manufacturing, not an AI-driven diagnostic device requiring expert interpretation of medical images or data. Ground truth here is established by standardized physical/chemical and biological testing methods, not expert consensus.
4. Adjudication method for the test set
- Not applicable. See point 3. Testing results are quantitative/qualitative measurements against established standards, not subject to human adjudication in the context of diagnostic interpretation.
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, not an AI or imaging device involving human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a material, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this device's performance is established by validated laboratory testing methods and industry standards (ISO standards) for physical/mechanical properties and biocompatibility.
- For mechanical properties: Quantitative measurements (e.g., flexural strength, water solubility) compared against specified limits in ISO 20975-1.
- For biocompatibility: Biological assays (e.g., cytotoxicity, genotoxicity) performed according to ISO 10993 series and evaluated against pass/fail criteria.
8. The sample size for the training set
- Not applicable. This is a material, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2017
Vertex-Dental BV c/o Patsy J. Trisler, JD, RAC Consultant Qserve Group US Inc. 5600 Wisconsin Avenue Chevy Chase. MD 20815
Re: K162572
Trade/Device Name: NextDent™ Denture/E-Denture Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: May 24, 2017 Received: May 24, 2017
Dear Patsy J. 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. 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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Andrew I. Steen -S
for Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K162572
Device Name
NextDentTM Denture / E-Denture
Indications for Use (Describe)
NextDent™ Denture / E-Denture is a light-cured resin indication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The material is an alternative to traditional heat cured and auto polymerization resins. NextDent ™ Denture is intended exclusively for professional dental work. Fabrication of denture bases with NextDent ™ Denture / E-Denture requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer and post-cure unt.
NextDent™ Denture / E-Denture is compatible with the following CAD/CAM systems components:
Design: Brand Type 3Shape D900 Scanner Design software 3Shape Dental-System 2016-Premium Printing: Brand Type Software Printer EnvisionTEC DDDP 4 Perfactory Rapidshape NetFabb D30 Miicraft 125Y MiiUtility MiiController 3D systems Figure 4 3D Sprint Roland DG DWP-80S Verl.1 Post-Curing: Brand Type NextDent TM LC-3D PrintBox Post-Cure unit
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.
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Section 5.0
510(k) SUMMARY--- NextDent™ Denture / E-Denture
| I. SUBMITTER | |
|---|---|
| Submitter Name: | Vertex-Dental B.V. |
| Submitter Address: | Centurionbaan 1903769 AV Soesterberg The Netherlands |
| Contact Person: | O.F. Beckeringh van Loenen |
| Telephone #: | +31 88 6160416 |
| Date Prepared: | June 29, 2017 |
| II. DEVICE | |
| Device Trade Name: | NextDent™ Denture E-Denture |
| Common andClassification Name(s): | Resin, Denture, Relining, Repairing, Rebasing |
| Classification #: | 21 CFR 872.3760 |
| Product Code | EBI |
| Regulatory Class | 2 |
| III. PREDICATE DEVICE(s) | Dentca Denture Base, K143033No reference devices were used in this submission. |
| IV. DEVICE DESCRIPTION | |
| Device Identification: | Light-Cure Resin, provided in a container. |
| Device Characteristics: | Denture Base Resins, Photo-Cured product family comprises a family of dimethacrylate resins. In general, the products in this family are composed of a 2-component dimethacrylic system, polymerized via photo initiators in a 3D printer setting. The color of the denture is determined by the addition of pigments. |
| Environment of Use: | Healthcare facility/hospital Dental (technical) laboratory. |
| Summary (Description) of Device: | NextDent™ Denture / E-Denture 3D-printing material is a light-cured resin indicated for the manufacturing of denture bases. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printing, the printed product is placed in a UV-light curing box for final polymerization.3D printer is not included with the device. |
| Materials of Use: | Dimethacrylate-based resins with photo-initiator, and |
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| V. INDICATIONS FOR USE | NextDent™ Denture / E-Denture is a light-cured resin indicated for the fabrication of denture bases fabricated in dental laboratories, including full and partial removable dentures. | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| The material is an alternative to traditional heat cured and auto polymerization resins. NextDent™ Denture / E-Denture is intended exclusively for professional dental work. | |||||||||||||||||||||||||
| Fabrication of denture bases with NextDent™ Denture / E-Denture requires a computer-aided and manufacturing (CAD/CAM) system that includes the following; scanner, design software, additive printer, and post-cure unit. | |||||||||||||||||||||||||
| NextDent™ Denture / E-Denture is compatible with the following CAD/CAM systems components: | |||||||||||||||||||||||||
| Design: | |||||||||||||||||||||||||
| Brand Type Scanner 3Shape D900 Design software 3Shape Dental-System 2016-Premium | |||||||||||||||||||||||||
| Printing: | |||||||||||||||||||||||||
| Printer Brand Type Software EnvisionTEC DDDP 4 Perfactory Rapidshape D30 NetFabb Miicraft 125Y MiiUtilityMiiController 3D systems Figure 4 3D Sprint Roland DG DWP-80S Ver1.1 | |||||||||||||||||||||||||
| Post-Curing: | |||||||||||||||||||||||||
| Post-cure unit NextDent LC-3DPrint Box | |||||||||||||||||||||||||
| VI. COMPARISON OFTECHNOLOGICALCHARACTERISTICS WITHTHE PREDICATE DEVICE | The Indications for Use statement of the predicated device Dentca Denture Base (K143033) is the following: | ||||||||||||||||||||||||
| "Dentca Denture Base is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat cured and auto polymerizing resins. | |||||||||||||||||||||||||
| Fabrication of dental prosthetics with Dentca Denture Base requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, stereolithographic additive printer, and curing light equipment." |
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| Both NextDent™ Denture / E-Denture and thepredicate device have the following similarcharacteristics: | |
|---|---|
| - Both devices are light-cure resins indicated forfabrication of removable full and partial denturebases. | |
| - Both devices require a CAD/CAM systemconsisting of a scanner, design software,additive printer and post-cure unit. | |
| NextDent™ Denture / E-Denture is not indicated forrepair of dentures because in our opinion thestereolithographic technique is not indicated for repairof denture bases. | |
| The difference is in the chemical composition of thespecific resin. | |
| NextDent™ Denture / E-Denture is similar to thepredicate device in the method of processing. Themain difference is the chemical composition of theresin. The chemical composition might influence thebiocompatibility of NextDent™ Denture's / E-Denture'sdenture base, as well as its performance (mechanicalproperties). Thus, both biocompatibility andperformance has been demonstrated for NextDent™Denture / E-Denture. The same tests according to thesame standards were used to show biocompatibilityand performance of the predicate. | |
| It was concluded, therefore, that the technologicaldifferences do not raise different questions of safetyand effectiveness. | |
| Based on the Device Comparison Table (section 12.2)and Comparison Demonstration SubstantialEquivalence (section 12.3) it was concluded (section12.4) that NextDent™ Denture / E-Denture,manufactured by Vertex-Dental, is substantiallyequivalent to the predicate device. | |
| VII. SUMMARY OFTESTING [PERFORMANCEDATA] | NextDent™ Denture / E-Denture has been tested formechanical properties as part of the productspecification. The most applicable standard formechanical characteristics determination of denturebase polymers and copolymers is the ISO 20975-1Dentistry - Base polymers - Part 1: Denture basepolymers. |
| Biocompatibility Testing: | NextDent™ Denture / E-Denture is considered asurface device, in contact with the mucosalmembrane, for > 30 days. |
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| The ISO 10993-1 standard was followed and the following biological safety aspects have been addressed: | |||||
|---|---|---|---|---|---|
| • | Cytotoxicity - ISO 10993-5 | ||||
| • | Sensitization - ISO 10993-10 | ||||
| • | Irritation or intracutaneous reactivity – ISO 10993-10 | ||||
| • | Subacute/subchronic systemic toxicity – ISO 10993-3 | ||||
| • | Genotoxicity - ISO 10993-3 | ||||
| In addition, the following risks have been considered based on a risk assessment, taking into account the specific nature and duration of exposure to the device | |||||
| • | Carcinogenicity | ||||
| • | Reproductive/developmental/organ toxicity | ||||
| • | Immunotoxicity | ||||
| • | Presence of phthalates | ||||
| Bench Testing | NextDent™ Denture / E-Denture has been tested for conformity with the industry standard ISO 20795-1. | ||||
| NextDent™ Denture / E-Denture is compliant to the requirements defined in ISO 20975-1 for Type 4 materials, except for water solubility which value slightly exceeds the requirement for Type 4 materials, but meets the requirement for Type 2 materials. | |||||
| NextDent™ Denture / E-Denture is compatible with the following CAD/CAM systems components: | |||||
| Design: | |||||
| Scanner | 3Shape | D900 | |||
| Design software | 3Shape | Dental-System 2016-Premium | |||
| Printing: | |||||
| Printer | Brand | Type | Software | ||
| EnvisionTEC | DDDP 4 | Perfactory | |||
| Rapidshape | D30 | NetFabb | |||
| Miicraft | 125Y | MiiUtilityMiiController | |||
| 3D systems | Figure 4 | 3D Sprint | |||
| Roland DG | DWP-80S | Ver1.1 | |||
| Post-Curing: | |||||
| Post-cure unit | NextDent | LC-3DPrint Box | |||
| The following bench tests are conducted on NextDent™ Denture / E-Denture using all the |
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| compatible CAD/CAM systems, including the postcuring process:Flexural strength Flexural modulus Water sorption Water solubility Residual monomer Biocompatibility | |
|---|---|
| Sterility and Shelf-LifeTesting | The device is provided non-sterile.From the Shelf life testing, NextDentTM Denture / E-Denture has a shelf life of 2 years.The shelf life testing has been conducted with thebench tests from the ISO standard 20975-1. |
| VIII. CONCLUSIONS | NextDentTM Denture / E-Denture and the predicatehave the same intended use and similar technologicalcharacteristics.The results of the performed tests show thatNextDentTM Denture / E-Denture meets therequirements mentioned in the applicable standards,and confirm that the device performs similarly to thepredicate device.It is therefore concluded that NextDentTM Denture /E-Denture performs as intended, and is substantiallyequivalent to the predicate device. |
§ 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.