(106 days)
K191497, NextDent Denture 3D+, Vertex-Dental BV
No
The summary describes a material (light-curable resin) and the associated hardware (scanner, design software, 3D printer, curing unit) used in a CAD/CAM system for fabricating denture bases. There is no mention of AI or ML being used in the design software, scanning process, or any other part of the system described. The focus is on the material properties and the manufacturing process.
No
The device is a material (light-curable resin) used for the fabrication of denture bases, which are medical devices, but the resin itself is not a therapeutic device. It is a component used in the manufacturing process.
No
Explanation: The device is a light-curable resin used for the fabrication of denture bases, which is a manufacturing process, not a diagnostic one.
No
The device description clearly states that the E-Denture Pro system includes hardware components such as a scanner, a 3D printer, and a curing unit, in addition to design software and the light-curable resin. It is a system that combines hardware and software for the fabrication of denture bases.
Based on the provided information, the E-Denture Pro device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fabrication of denture bases fabricated in dental laboratories for full removable dentures." This is a manufacturing process for a medical device (a denture base), not a diagnostic test performed on a biological sample.
- Device Description: The description details the components used in the manufacturing process (scanner, software, resin, printer, curing unit) and the composition of the resin. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the manufactured denture base (flexural strength, dimensional stability, biocompatibility), which are relevant to the function and safety of a medical device, not a diagnostic test.
In summary, the E-Denture Pro is a system for manufacturing a medical device (a denture base) and does not fit the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
E-Denture Pro is a light-curable resin indicated for the fabrication of denture bases fabricated in dental laboratories for full removable dentures. The material is an alternative to traditional heat-curable and auto polymerizing resins. E-Denture Pro is intended exclusively for professional dental work. Fabrication of denture bases with E-Denture Pro requires a computer-aided and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, a digital light processing (DLP) printer, and curing light equipment.
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
The E-Denture Pro system combines a scanner with design software, the light-curable resin, a 3D printer and a curing unit. These components are used together during the manufacture of the customized denture base for the removable full denture.
The light-curable resin is a proprietary composition of acrylates, methacrylates, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories and dental practices to make the denture bases for removable full dentures. The resin is offered in lightproof 1 kg PE bottles along with a programmed chip (referred to as TAG), which is required for use with the 3D printer. The TAG contains information identifying the resin material, name and amount. E-Denture Pro resin is an alternative material to heat-curable and auto-polymerizable resins. EnvisionTECs Perfactory® 3D-Printer models designed and validated for use with the E-Denture Pro light cured resin are: EnvisionOne cDLM, with LED Vida Series, with LED P4K Series, with LED D4K Series, with LED
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
professional dental work / dental laboratories
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)
Laboratory Testing:
Testing was conducted to evaluate the performance of a manufactured denture base, according to requirements of DIN EN ISO 20795-1:2013, Dentistry – Base Polymers. Including biocompatibility requirements, the following specification requirements of the 3D-printed denture base material samples were tested and have been met: Surface quality, Dimensional stability, Color and color stability, Translucency, Flexural strength and flexural modulus, Freedom from porosity, Bonding to synthetic teeth, Residual monomer, Sorption, Solubility
Shelf Life Testing:
Validated real-time shelf life of the E-Denture Pro resin at time of 510(k) submission is 3 months. The resin is on real-time validation testing for an ultimate shelf life of 24 months, stored in the original packaging at temperatures at 30° C. Properties being tested include material viscosity, material photoreactivity and color change. Resin also was tested for good transport stability.
Biocompatibility Testing:
Testing, according to ISO 10993 and Good Laboratory Practices, confirms that E-Denture Pro denture base is biocompatible and non-toxic and meets the requirements for a device in contact with mucosal membrane for >30 days. A biocompatibility risk assessment was developed and presented in the 510(k). As a result the following ISO 10993 tests were conducted and results met the requirements of each test:
• Cytotoxicity Study Using ISO Elution Method (Part 5)
• Guinea Pig Maximization Sensitization Test (Part 10)
• Tests for Irritation and Skin Sensitization – Intracutaneous Injection in Rabbits (Part 10)
• Acute Systemic Toxicity in Mice (Part 11)
Additive Manufacturing:
Testing, according to FDA's guidance Technical Considerations for Additive Manufactured Medical Devices, was performed and results were provided in the 510(k). These tests included evaluation of all relevant properties of the printed resin using the permitted machines. Further, tests based on considerations of the orientation during manufacturing were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength (comparative testing): 72.7 MPa
Secant Modulus (comparative testing): 2192 MPa
Flexural Strain (comparative testing): >5.0 % at break
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.
K191497, NextDent Denture 3D+, Vertex-Dental BV
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.
K102776, e-DENT Temporary Resin and Extra-Oral Curing System, DeltaMed GmbH
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
March 30, 2021
EnvisionTEC GmbH % Patsy Trisler Regulatory Consultant Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250
Re: K203641
Trade/Device Name: E-Denture Pro Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: March 4, 2021 Received: March 8, 2021
Dear Patsy Trisler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
EnvisionTEC E-Denture Pro
Indications for Use (Describe)
E-Denture Pro is a light-curable resin indicated for the fabrication of denture bases fabricated in dental laboratories for full removable dentures. The material is an alternative to traditional heat-curable and auto polymerizing resins. E-Denture Pro is intended exclusively for professional dental work. Fabrication of denture bases with E-Denture Pro requires a computer-aided and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, a digital light processing (DLP) printer, and curing light equipment.
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) |
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510(k) Summary – K203641
| I. SUBMITTER | |
|---|---|
| Submitter Name: | EnvisionTEC GmbH |
| Submitter Address: | Bruesseler Straße 51 |
| D-45968 Gladbeck | |
| Germany | |
| Contact Person: | Ruediger van Bernum, Head of Application |
| Email: | ruediger.v.bernum@envisiontec.de |
| Telephone: | +49 2043 987545 |
| Date Prepared: | March 26, 2021 |
| II. DEVICE | |
| Trade Name: | E-Denture Pro |
| Common Name | Denture Resin |
| Classification: | |
| Name Number | |
| Product Code | |
| Device Class | Denture Relining, Repairing, or Rebasing Resin 21 CFR 872.3760 |
| EBI | |
| II | |
| III. PREDICATE DEVICE | |
| Primary | |
| Predicate Device: | K191497, NextDent Denture 3D+, Vertex-Dental BV |
| Reference Device | K102776, e-DENT Temporary Resin and Extra-Oral Curing System, |
| DeltaMed GmbH | |
| IV. INDICATIONS FOR USE STATEMENT | |
| E-Denture Pro is a light-curable resin indicated for the fabrication of denture bases | |
| fabricated in dental laboratories for full removable dentures. The material is an alternative | |
| to traditional heat-curable and auto polymerizing resins. E-Denture Pro is intended | |
| exclusively for professional dental work. Fabrication of denture bases with E-Denture Pro | |
| requires a computer-aided and manufacturing (CAD/CAM) system that includes the | |
| following components: digital denture base files based on a digital impression, a digital | |
| light processing (DLP) printer, and curing light equipment. | |
| V. DEVICE DESCRIPTION | |
| Device | |
| Identification | The E-Denture Pro system combines a scanner with design |
| software, the light-curable resin, a 3D printer and a curing unit. | |
| These components are used together during the manufacture of the | |
| customized denture base for the removable full denture. | |
| Technological | |
| Characteristics | The light-curable resin is a proprietary composition of acrylates, |
| methacrylates, methacrylated oligomers and monomers, photo | |
| initiators, colorants/dyes and absorbers. It is used by dental | |
| laboratories and dental practices to make the denture bases for | |
| removable full dentures. |
4
| The resin is offered in lightproof 1 kg PE bottles along with a
programmed chip (referred to as TAG), which is required for use
with the 3D printer. The TAG contains information identifying the
resin material, name and amount.
E-Denture Pro resin is an alternative material to heat-curable and
auto-polymerizable resins.
EnvisionTECs Perfactory® 3D-Printer models designed and
validated for use with the E-Denture Pro light cured resin are:
EnvisionOne cDLM, with LED
Vida Series, with LED
P4K Series, with LED
| D4K Series, with LED | ||
|---|---|---|
| VI. SUBSTANTIAL EQUIVALENCE COMPARISON TABLE | ||
| NEW DEVICE | PRIMARY PREDICATE | |
| 510(k) NUMBER; | K203641 | K191497 |
| DEVICE NAME; | E-Denture Pro | NextDent Denture 3D+ |
| MANUFACTURER | EnvisionTEC GmbH | Vertex-Dental BV |
| PRODUCT CODE | EBI | EBI |
| REGULATORY NAME | Denture Relining, Repairing, or | |
| Rebasing Resin | Denture Relining, Repairing, or | |
| Rebasing Resin | ||
| CLASSIFICATION | 21 CFR 872.3760 | 21 CFR 872.3760 |
| INDICATIONS FOR | ||
| USE | E-Denture Pro is a light-curable | |
| resin indicated for the fabrication | ||
| of denture bases fabricated in | ||
| dental laboratories for full | ||
| removable dentures. The | ||
| material is an alternative to | ||
| traditional heat-curable and auto | ||
| polymerizing resins. E-Denture | ||
| Pro is intended exclusively for | ||
| professional dental work. | ||
| Fabrication of denture bases with | ||
| E-Denture Pro requires a | ||
| computer-aided and | ||
| manufacturing (CAD/CAM) | ||
| system that includes the following | ||
| components: digital denture base | ||
| files based on a digital | ||
| impression, a digital light | ||
| processing (DLP) printer, and | ||
| curing light equipment. | NextDent Denture 3D+ 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 3D+ is intended | ||
| exclusively for professional dental | ||
| work. Fabrication of denture bases | ||
| with NextDent Denture 3D+ requires | ||
| a computer-aided and | ||
| manufacturing (CAD/CAM) system | ||
| that includes the following scanner, | ||
| design software, additive printer and | ||
| post-cure unit: | ||
| Design: | ||
| Scanner: 3Shape D900 | ||
| Design Software: 3Shape Dental- | ||
| System 2016 Premium | ||
| Printing: | ||
| Printer: 3D Systems NextDent 5100 | ||
| Figure 4®; Software: 3D Sprint | ||
| Post-curing: | ||
| Post-cure unit: NextDent LC-3D | ||
| Print Box |
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| INGREDIENTS | Light-curable Resin | Light-curable Resin |
|---|---|---|
| MANUFACTURING | ||
| TECHNOLOGY TYPE | Additive | Additive |
| PRODUCT | ||
| CHARACTERISTICS: | ||
| Sterility | Non-sterile | Non-sterile |
| Flexural Strength | ||
| (comparative testing) | 72.7 MPa | 81.2 MPa |
| Secant Modulus | ||
| (comparative testing) | 2192 MPa | 3113 MPa |
| Flexural Strain | ||
| (comparative testing) | >5.0 % at break | 2.8 % at break |
| Biocompatibility | Biocompatible, according to ISO | |
| 10993 testing | Biocompatible, according to ISO | |
| 10993 testing | ||
| VII PERFORMANCE AND SAFETY TESTING | ||
| Animal Testing: | This product category does not require animal testing. | |
| Clinical Testing: | This product category does not require human clinical testing. | |
| Laboratory | ||
| Testing: | Testing was conducted to evaluate the performance of a | |
| manufactured denture base, according to requirements of DIN EN | ||
| ISO 20795-1:2013, Dentistry – Base Polymers. |
Including biocompatibility requirements, the following specification
requirements of the 3D-printed denture base material samples
were tested and have been met:
Surface qualityDimensional stabilityColor and color stabilityTranslucencyFlexural strength and flexural modulusFreedom from porosityBonding to synthetic teethResidual monomerSorptionSolubility | |
| Shelf Life Testing: | Validated real-time shelf life of the E-Denture Pro resin at time of
510(k) submission is 3 months. The resin is on real-time validation
testing for an ultimate shelf life of 24 months, stored in the original
packaging at temperatures at 30° C. Properties being tested
include material viscosity, material photoreactivity and color
change. Resin also was tested for good transport stability. | |
| Biocompatibility
Testing: | Testing, according to ISO 10993 and Good Laboratory Practices,
confirms that E-Denture Pro denture base is biocompatible and
non-toxic and meets the requirements for a device in contact with
mucosal membrane for >30 days. A biocompatibility risk
assessment was developed and presented in the 510(k). As a
result the following ISO 10993 tests were conducted and results | |
| | met the requirements of each test: | |
| | • Cytotoxicity Study Using ISO Elution Method (Part 5) | |
| | • Guinea Pig Maximization Sensitization Test (Part 10) | |
| | • Tests for Irritation and Skin Sensitization – Intracutaneous
Injection in Rabbits (Part 10) | |
| | • Acute Systemic Toxicity in Mice (Part 11) | |
| Additive
Manufacturing | Testing, according to FDA's guidance Technical Considerations for
Additive Manufactured Medical Devices, was performed and
results were provided in the 510(k). These tests included
evaluation of all relevant properties of the printed resin using the
permitted machines. Further, tests based on considerations of the
orientation during manufacturing were performed. | |
6
VIII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES
The intended use, critical specifications, and additive method of manufacturing of E-Denture Pro are substantially equivalent to the predicate device, NextDent Denture 3D+.
While the resin of the predicate is different from E-Denture Pro, both are photo-curable resins used in additive manufacturing and are of the same material category, and the software is the same as used in 3D-printing the Reference device.
The additive manufacturing processes both use a resin, scanner, printer and curing unit.
The testing performed by EnvisionTEC, directly compared to the predicate produced results that are similar to the predicate.
The noted differences, in comparison to the predicate device, raise no new questions of safety and effectiveness.
VIX CONCLUSION
Based on the comparisons provided and the data submitted in this 510(k), it can be concluded E-Denture Pro is substantially equivalent to the predicate device. EnvisionTEC's analysis of E-Denture Pro compared to the predicate show they have the same intended use, and technological parameters that meet the requirements of ISO 20795-1:2003.