(288 days)
No reference devices were used in this submission.
No
The summary describes a 3D printing material and the associated CAD/CAM system for fabricating denture bases. There is no mention of AI or ML being used in the design software, scanning, printing, or post-curing processes. The performance studies focus on material properties and biocompatibility, not algorithmic performance.
No
This device is a material (resin) for fabricating denture bases, which are prosthetic devices, not therapeutic devices.
No.
This device is a light-cured resin material used for fabricating denture bases, which is a therapeutic rather than a diagnostic function.
No
The device is a light-cured resin material used in a 3D printing process to fabricate denture bases. It 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 is for fabricating denture bases, which are physical prosthetics used in the mouth. This is a therapeutic/restorative application, not a diagnostic one.
- Device Description: The device is a 3D printing material used to create a physical object (a denture base). It does not interact with biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Performance Studies: The performance studies focus on mechanical properties, biocompatibility, and compliance with standards for denture base materials. These are relevant to the physical and biological interaction of the device with the patient, not to diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
Light-Cure Resin, provided in a container.
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.
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
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
Environment of Use: Healthcare facility/hospital Dental (technical) laboratory.
NextDent™ Denture / E-Denture is intended exclusively for professional dental work.
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™ Denture / E-Denture has been tested for mechanical properties as part of the product specification. The most applicable standard for mechanical characteristics determination of denture base polymers and copolymers is the ISO 20975-1 Dentistry - Base polymers - Part 1: Denture base polymers.
Biocompatibility Testing: NextDent™ Denture / E-Denture is considered a surface device, in contact with the mucosal membrane, for > 30 days.
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:
Brand Type Software
EnvisionTEC DDDP 4 Perfactory
Rapidshape D30 NetFabb
Miicraft 125Y MiiUtility MiiController
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 compatible CAD/CAM systems, including the post curing process:
Flexural strength Flexural modulus Water sorption Water solubility Residual monomer Biocompatibility
Sterility and Shelf-Life Testing: 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 the bench tests from the ISO standard 20975-1.
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.
Dentca Denture Base, K143033
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.
No reference devices were used in this submission.
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/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.
1
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
2
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.
3
Section 5.0
510(k) SUMMARY--- NextDent™ Denture / E-Denture
| I. SUBMITTER | |
|---|---|
| Submitter Name: | Vertex-Dental B.V. |
| Submitter Address: | Centurionbaan 190 |
| 3769 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 and | |
| Classification 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, K143033 |
| No 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 |
4
| 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 MiiUtility | |||||||||||||||||||||||||
| MiiController 3D systems Figure 4 3D Sprint Roland DG DWP-80S Ver1.1 | |||||||||||||||||||||||||
| Post-Curing: | |||||||||||||||||||||||||
| Post-cure unit NextDent LC-3DPrint Box | |||||||||||||||||||||||||
| VI. COMPARISON OF | |||||||||||||||||||||||||
| TECHNOLOGICAL | |||||||||||||||||||||||||
| CHARACTERISTICS WITH | |||||||||||||||||||||||||
| THE 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." |
5
| | Both NextDent™ Denture / E-Denture and the
predicate device have the following similar
characteristics: |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - Both devices are light-cure resins indicated for
fabrication of removable full and partial denture
bases. |
| | - Both devices require a CAD/CAM system
consisting of a scanner, design software,
additive printer and post-cure unit. |
| | NextDent™ Denture / E-Denture is not indicated for
repair of dentures because in our opinion the
stereolithographic technique is not indicated for repair
of denture bases. |
| | The difference is in the chemical composition of the
specific resin. |
| | NextDent™ Denture / E-Denture is similar to the
predicate device in the method of processing. The
main difference is the chemical composition of the
resin. The chemical composition might influence the
biocompatibility of NextDent™ Denture's / E-Denture's
denture base, as well as its performance (mechanical
properties). Thus, both biocompatibility and
performance has been demonstrated for NextDent™
Denture / E-Denture. The same tests according to the
same standards were used to show biocompatibility
and performance of the predicate. |
| | It was concluded, therefore, that the technological
differences do not raise different questions of safety
and effectiveness. |
| | Based on the Device Comparison Table (section 12.2)
and Comparison Demonstration Substantial
Equivalence (section 12.3) it was concluded (section
12.4) that NextDent™ Denture / E-Denture,
manufactured by Vertex-Dental, is substantially
equivalent to the predicate device. |
| VII. SUMMARY OF
TESTING [PERFORMANCE
DATA] | NextDent™ Denture / E-Denture has been tested for
mechanical properties as part of the product
specification. The most applicable standard for
mechanical characteristics determination of denture
base polymers and copolymers is the ISO 20975-1
Dentistry - Base polymers - Part 1: Denture base
polymers. |
| Biocompatibility Testing: | NextDent™ Denture / E-Denture is considered a
surface device, in contact with the mucosal
membrane, for > 30 days. |
6
| 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 | MiiUtility | |||
| MiiController | |||||
| 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 |
7
| | compatible CAD/CAM systems, including the post
curing process:
Flexural strength Flexural modulus Water sorption Water solubility Residual monomer Biocompatibility |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterility and Shelf-Life
Testing | 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 the
bench tests from the ISO standard 20975-1. |
| VIII. CONCLUSIONS | NextDentTM Denture / E-Denture and the predicate
have the same intended use and similar technological
characteristics.
The results of the performed tests show that
NextDentTM Denture / E-Denture meets the
requirements mentioned in the applicable standards,
and confirm that the device performs similarly to the
predicate device.
It is therefore concluded that NextDentTM Denture /
E-Denture performs as intended, and is substantially
equivalent to the predicate device. |