E-Denture Pro

K203641 · Envisiontec GmbH · EBI · Mar 30, 2021 · Dental

Device Facts

• Record ID: K203641
• Device Name: E-Denture Pro
• Applicant: Envisiontec GmbH
• Product Code: EBI · Dental
• Decision Date: Mar 30, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended 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.

Device Story

E-Denture Pro is a light-curable resin for additive manufacturing of denture bases. Input: digital denture base files derived from digital impressions. Process: CAD/CAM system uses DLP printer to cure resin; post-curing required. Output: custom denture base for full removable dentures. Used in dental laboratories by dental professionals. Resin supplied in lightproof bottles with programmed 'TAG' chip for printer identification. Benefits: alternative to traditional heat-curable/auto-polymerizing resins; enables digital workflow for denture fabrication.

Clinical Evidence

No clinical data. Bench testing only. Evaluated per DIN EN ISO 20795-1:2013 (base polymers) and FDA additive manufacturing guidance. Tests included surface quality, dimensional stability, color stability, translucency, flexural strength (72.7 MPa), flexural modulus, porosity, bonding to synthetic teeth, residual monomer, sorption, and solubility. Biocompatibility confirmed via ISO 10993 (cytotoxicity, sensitization, irritation, acute systemic toxicity).

Technological Characteristics

Light-curable resin composed of acrylates, methacrylates, methacrylated oligomers/monomers, photo initiators, colorants, and absorbers. Additive manufacturing (DLP). Non-sterile. Requires programmed TAG chip for printer compatibility. Validated for EnvisionOne cDLM, Vida, P4K, and D4K series printers.

Indications for Use

Indicated for fabrication of denture bases for full removable dentures in dental laboratories. Intended for professional dental use only. Requires CAD/CAM system (digital impression files, DLP printer, curing light).

Regulatory Classification

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.

Predicate Devices

• NextDent Denture 3D+ (K191497)

Reference Devices

• e-DENT Temporary Resin and Extra-Oral Curing System (K102776)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K203641

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)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | 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<br>D-45968 Gladbeck<br>Germany |
| Contact Person: | Ruediger van Bernum, Head of Application |
| Email: | [e-mail] |
| Telephone: | [phone] |
| Date Prepared: | March 26, 2021 |
| II. DEVICE | |
| Trade Name: | E-Denture Pro |
| Common Name | Denture Resin |
| Classification:<br>Name Number<br>Product Code<br>Device Class | Denture Relining, Repairing, or Rebasing Resin 21 CFR 872.3760<br>EBI<br>II |
| III. PREDICATE DEVICE | |
| Primary<br>Predicate Device: | K191497, NextDent Denture 3D+, Vertex-Dental BV |
| Reference Device | K102776, e-DENT Temporary Resin and Extra-Oral Curing System,<br>DeltaMed GmbH |
| IV. INDICATIONS FOR USE STATEMENT | |
| E-Denture Pro is a light-curable resin indicated for the fabrication of denture bases<br>fabricated in dental laboratories for full removable dentures. The material is an alternative<br>to traditional heat-curable and auto polymerizing resins. E-Denture Pro is intended<br>exclusively for professional dental work. Fabrication of denture bases with E-Denture Pro<br>requires a computer-aided and manufacturing (CAD/CAM) system that includes the<br>following components: digital denture base files based on a digital impression, a digital<br>light processing (DLP) printer, and curing light equipment. | |
| V. DEVICE DESCRIPTION | |
| Device<br>Identification | The E-Denture Pro system combines a scanner with design<br>software, the light-curable resin, a 3D printer and a curing unit.<br>These components are used together during the manufacture of the<br>customized denture base for the removable full denture. |
| Technological<br>Characteristics | The light-curable resin is a proprietary composition of acrylates,<br>methacrylates, methacrylated oligomers and monomers, photo<br>initiators, colorants/dyes and absorbers. It is used by dental<br>laboratories and dental practices to make the denture bases for<br>removable full dentures. |

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| The resin is offered in lightproof 1 kg PE bottles along with a<br>programmed chip (referred to as TAG), which is required for use<br>with the 3D printer. The TAG contains information identifying the<br>resin material, name and amount.<br>E-Denture Pro resin is an alternative material to heat-curable and<br>auto-polymerizable resins.<br>EnvisionTECs Perfactory® 3D-Printer models designed and<br>validated for use with the E-Denture Pro light cured resin are:<br>EnvisionOne cDLM, with LED<br>Vida Series, with LED<br>P4K Series, with LED<br>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<br>Rebasing Resin | Denture Relining, Repairing, or<br>Rebasing Resin |
| CLASSIFICATION | 21 CFR 872.3760 | 21 CFR 872.3760 |
| INDICATIONS FOR<br>USE | E-Denture Pro is a light-curable<br>resin indicated for the fabrication<br>of denture bases fabricated in<br>dental laboratories for full<br>removable dentures. The<br>material is an alternative to<br>traditional heat-curable and auto<br>polymerizing resins. E-Denture<br>Pro is intended exclusively for<br>professional dental work.<br>Fabrication of denture bases with<br>E-Denture Pro requires a<br>computer-aided and<br>manufacturing (CAD/CAM)<br>system that includes the following<br>components: digital denture base<br>files based on a digital<br>impression, a digital light<br>processing (DLP) printer, and<br>curing light equipment. | NextDent Denture 3D+ is a light-<br>cured resin indicated for the<br>fabrication of denture bases<br>fabricated in dental laboratories,<br>including full and partial removable<br>dentures. The material is an<br>alternative to traditional heat-cured<br>and auto polymerization resins.<br>NextDent Denture 3D+ is intended<br>exclusively for professional dental<br>work. Fabrication of denture bases<br>with NextDent Denture 3D+ requires<br>a computer-aided and<br>manufacturing (CAD/CAM) system<br>that includes the following scanner,<br>design software, additive printer and<br>post-cure unit:<br>Design:<br>Scanner: 3Shape D900<br>Design Software: 3Shape Dental-<br>System 2016 Premium<br>Printing:<br>Printer: 3D Systems NextDent 5100<br>Figure 4®; Software: 3D Sprint<br>Post-curing:<br>Post-cure unit: NextDent LC-3D<br>Print Box |

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| INGREDIENTS | Light-curable Resin | Light-curable Resin |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| MANUFACTURING<br>TECHNOLOGY TYPE | Additive | Additive |
| PRODUCT<br>CHARACTERISTICS:<br>Sterility | Non-sterile | Non-sterile |
| Flexural Strength<br>(comparative testing) | 72.7 MPa | 81.2 MPa |
| Secant Modulus<br>(comparative testing) | 2192 MPa | 3113 MPa |
| Flexural Strain<br>(comparative testing) | >5.0 % at break | 2.8 % at break |
| Biocompatibility | Biocompatible, according to ISO<br>10993 testing | Biocompatible, according to ISO<br>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<br>Testing: | Testing was conducted to evaluate the performance of a<br>manufactured denture base, according to requirements of DIN EN<br>ISO 20795-1:2013, Dentistry – Base Polymers.<br><br>Including biocompatibility requirements, the following specification<br>requirements of the 3D-printed denture base material samples<br>were tested and have been met:<br>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<br>510(k) submission is 3 months. The resin is on real-time validation<br>testing for an ultimate shelf life of 24 months, stored in the original<br>packaging at temperatures at 30° C. Properties being tested<br>include material viscosity, material photoreactivity and color<br>change. Resin also was tested for good transport stability. | |
| Biocompatibility<br>Testing: | Testing, according to ISO 10993 and Good Laboratory Practices,<br>confirms that E-Denture Pro denture base is biocompatible and<br>non-toxic and meets the requirements for a device in contact with<br>mucosal membrane for >30 days. A biocompatibility risk<br>assessment was developed and presented in the 510(k). As a<br>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<br>Injection in Rabbits (Part 10) | |
| | • Acute Systemic Toxicity in Mice (Part 11) | |
| <b>Additive<br/>Manufacturing</b> | Testing, according to FDA's guidance Technical Considerations for<br>Additive Manufactured Medical Devices, was performed and<br>results were provided in the 510(k). These tests included<br>evaluation of all relevant properties of the printed resin using the<br>permitted machines. Further, tests based on considerations of the<br>orientation 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.