(106 days)
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.
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
The document is a 510(k) Summary for the EnvisionTEC E-Denture Pro, a light-curable resin for fabricating denture bases. The study outlined is a bench testing study comparing the E-Denture Pro to a predicate device and relevant standards, not a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable to this type of device and study.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the requirements of DIN EN ISO 20795-1:2013, Dentistry – Base Polymers and ISO 10993 for biocompatibility. The reported device performance is compared with the predicate device (K191497, NextDent Denture 3D+).
| Acceptance Criteria (Standard / Predicate Device) | Reported Device Performance (E-Denture Pro) | Outcome |
|---|---|---|
| Material Properties (DIN EN ISO 20795-1:2013) | (Tested and met requirements) | Met |
| - Surface quality | (Met requirements) | Met |
| - Dimensional stability | (Met requirements) | Met |
| - Color and color stability | (Met requirements) | Met |
| - Translucency | (Met requirements) | Met |
| - Freedom from porosity | (Met requirements) | Met |
| - Bonding to synthetic teeth | (Met requirements) | Met |
| - Residual monomer | (Met requirements) | Met |
| - Sorption | (Met requirements) | Met |
| - Solubility | (Met requirements) | Met |
| Biocompatibility (ISO 10993) | (Biocompatible, non-toxic) | Met |
| - Cytotoxicity Study (Part 5) | (Met requirements) | Met |
| - Guinea Pig Maximization Sensitization Test (Part 10) | (Met requirements) | Met |
| - Intracutaneous Injection in Rabbits (Part 10) | (Met requirements) | Met |
| - Acute Systemic Toxicity in Mice (Part 11) | (Met requirements) | Met |
| Flexural Strength (Predicate: 81.2 MPa) | 72.7 MPa | Similar |
| Secant Modulus (Predicate: 3113 MPa) | 2192 MPa | Similar |
| Flexural Strain (Predicate: 2.8 % at break) | >5.0 % at break | Similar |
Note: The document states that the testing "produced results that are similar to the predicate" and that "the noted differences... raise no new questions of safety and effectiveness." This implies the performance values for Flexural Strength, Secant Modulus, and Flexural Strain, while not identical, are considered acceptable by the FDA for substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes (number of specimens or denture bases) used for each physical and chemical test.
- Data Provenance: The data is from laboratory testing conducted by EnvisionTEC, likely in Germany (based on the submitter's address). This is considered prospective data generation for the purpose of regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a materials science and engineering characterization study, not an expert-based diagnostic or classification study. The "ground truth" is established by the specified international standards (DIN EN ISO 20795-1:2013 and ISO 10993).
4. Adjudication method for the test set
Not applicable. The tests are quantifiable material property measurements against established standards, not subject to expert adjudication.
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 is not an AI-assisted diagnostic device, nor a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a material (resin) used in a CAD/CAM system, not a standalone algorithm.
7. The type of ground truth used
The ground truth used for performance evaluation is based on:
- International Standards: DIN EN ISO 20795-1:2013 (Dentistry – Base Polymers) for mechanical and physical properties of denture bases.
- International Biocompatibility Standards: ISO 10993 for biological evaluation of medical devices.
- Comparison to a Legally Marketed Predicate Device: The performance is also benchmarked against the NextDent Denture 3D+ (K191497) to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable (as there is no training set).
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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
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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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r
510(k) Summary – K203641
| I. SUBMITTER | |
|---|---|
| Submitter Name: | EnvisionTEC GmbH |
| Submitter Address: | Bruesseler Straße 51D-45968 GladbeckGermany |
| 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 NumberProduct CodeDevice Class | Denture Relining, Repairing, or Rebasing Resin 21 CFR 872.3760EBIII |
| III. PREDICATE DEVICE | |
| PrimaryPredicate 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 basesfabricated in dental laboratories for full removable dentures. The material is an alternativeto traditional heat-curable and auto polymerizing resins. E-Denture Pro is intendedexclusively for professional dental work. Fabrication of denture bases with E-Denture Prorequires a computer-aided and manufacturing (CAD/CAM) system that includes thefollowing components: digital denture base files based on a digital impression, a digitallight processing (DLP) printer, and curing light equipment. | |
| V. DEVICE DESCRIPTION | |
| DeviceIdentification | The E-Denture Pro system combines a scanner with designsoftware, the light-curable resin, a 3D printer and a curing unit.These components are used together during the manufacture of thecustomized denture base for the removable full denture. |
| TechnologicalCharacteristics | The light-curable resin is a proprietary composition of acrylates,methacrylates, methacrylated oligomers and monomers, photoinitiators, colorants/dyes and absorbers. It is used by dentallaboratories and dental practices to make the denture bases forremovable full dentures. |
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| The resin is offered in lightproof 1 kg PE bottles along with aprogrammed chip (referred to as TAG), which is required for usewith the 3D printer. The TAG contains information identifying theresin material, name and amount.E-Denture Pro resin is an alternative material to heat-curable andauto-polymerizable resins.EnvisionTECs Perfactory® 3D-Printer models designed andvalidated for use with the E-Denture Pro light cured resin are:EnvisionOne cDLM, with LEDVida Series, with LEDP4K Series, with LEDD4K 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, orRebasing Resin | Denture Relining, Repairing, orRebasing Resin |
| CLASSIFICATION | 21 CFR 872.3760 | 21 CFR 872.3760 |
| INDICATIONS FORUSE | E-Denture Pro is a light-curableresin indicated for the fabricationof denture bases fabricated indental laboratories for fullremovable dentures. Thematerial is an alternative totraditional heat-curable and autopolymerizing resins. E-DenturePro is intended exclusively forprofessional dental work.Fabrication of denture bases withE-Denture Pro requires acomputer-aided andmanufacturing (CAD/CAM)system that includes the followingcomponents: digital denture basefiles based on a digitalimpression, a digital lightprocessing (DLP) printer, andcuring light equipment. | NextDent Denture 3D+ is a light-cured resin indicated for thefabrication of denture basesfabricated in dental laboratories,including full and partial removabledentures. The material is analternative to traditional heat-curedand auto polymerization resins.NextDent Denture 3D+ is intendedexclusively for professional dentalwork. Fabrication of denture baseswith NextDent Denture 3D+ requiresa computer-aided andmanufacturing (CAD/CAM) systemthat includes the following scanner,design software, additive printer andpost-cure unit:Design:Scanner: 3Shape D900Design Software: 3Shape Dental-System 2016 PremiumPrinting:Printer: 3D Systems NextDent 5100Figure 4®; Software: 3D SprintPost-curing:Post-cure unit: NextDent LC-3DPrint Box |
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| INGREDIENTS | Light-curable Resin | Light-curable Resin |
|---|---|---|
| MANUFACTURINGTECHNOLOGY TYPE | Additive | Additive |
| PRODUCTCHARACTERISTICS: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 ISO10993 testing | Biocompatible, according to ISO10993 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. | |
| LaboratoryTesting: | Testing was conducted to evaluate the performance of amanufactured denture base, according to requirements of DIN ENISO 20795-1:2013, Dentistry – Base Polymers.Including biocompatibility requirements, the following specificationrequirements of the 3D-printed denture base material sampleswere 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 of510(k) submission is 3 months. The resin is on real-time validationtesting for an ultimate shelf life of 24 months, stored in the originalpackaging at temperatures at 30° C. Properties being testedinclude material viscosity, material photoreactivity and colorchange. Resin also was tested for good transport stability. | |
| BiocompatibilityTesting: | Testing, according to ISO 10993 and Good Laboratory Practices,confirms that E-Denture Pro denture base is biocompatible andnon-toxic and meets the requirements for a device in contact withmucosal membrane for >30 days. A biocompatibility riskassessment was developed and presented in the 510(k). As aresult 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 – IntracutaneousInjection in Rabbits (Part 10) | ||
| • Acute Systemic Toxicity in Mice (Part 11) | ||
| AdditiveManufacturing | Testing, according to FDA's guidance Technical Considerations forAdditive Manufactured Medical Devices, was performed andresults were provided in the 510(k). These tests includedevaluation of all relevant properties of the printed resin using thepermitted machines. Further, tests based on considerations of theorientation during manufacturing were performed. |
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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.
§ 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.