GR-14 Resin System

K210298 · Pro3Dure Medical GmbH · EBI · May 5, 2021 · Dental

Device Facts

• Record ID: K210298
• Device Name: GR-14 Resin System
• Applicant: Pro3Dure Medical GmbH
• Product Code: EBI · Dental
• Decision Date: May 5, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

The GR-14.1 denture is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.1 denture is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates. The GR-14.2 denture HI is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.2 denture HI is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

Device Story

GR-14 Resin System consists of light-curable liquid methacrylic resins with inorganic fillers; available in three shades. Used in dental laboratories for additive manufacturing of denture baseplates. Requires integration with CAD/CAM systems (e.g., Nyomo, Rapidshape, Envisiontec, Asiga) and 405nm image projection systems for polymerization. Preformed teeth are attached via separate gluing process. Final output is a custom denture baseplate. Benefits include alternative to traditional heat-cured or auto-polymerization methods for dental prosthetics.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 20795-1 and ISO 22112, including flexural strength, flexural modulus, bond strength, color stability, water sorption, solubility, and fracture toughness. Biocompatibility tested per ISO 10993-1 and ISO 7405. Shelf-life validated per ASTM F1980-16.

Technological Characteristics

Liquid photo-curable multifunctional methacrylates/dimethacrylates with inorganic fillers. Polymerization via 405nm light. Complies with ISO 20795-1 and ISO 22112. Biocompatible per ISO 10993 and ISO 7405. Shelf life 2 years (ASTM F1980-16).

Indications for Use

Indicated for the fabrication and repair of full and partial removable dentures and baseplates via additive manufacturing in dental laboratories.

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)
• Dentca Denture Base II (K162044)

Reference Devices

• Pro3dure GR-17 Resin System (K201827)

Submission Summary (Full Text)

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May 5, 2021

Pro3dure Medical GmbH % Patricia Kontoudis Senior Specialist, Regulatory Affairs Regulatory and Quality Solutions, LLC 2790 Mosside Blvd., Suite 800 Monroeville, Pennsylvania 15146

Re: K210298

Trade/Device Name: GR-14 Resin System 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 9, 2021

Dear Patricia Kontoudis:

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

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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 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 (QS) 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 medical devices and radiation-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 and ENT 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) k210298

Device Name GR-14 Resin System

#### Indications for Use (Describe)

The GR-14.1 denture is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.1 denture is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

The GR-14.2 denture HI is a light-curable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.2 denture HI is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:10pt">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10pt">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 5. 510(k) Summary - K210298

| Device Trade Name: | GR-14 Resin System | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Manufacturer: | Pro3dure Medical GmbH<br>Am Burgberg 13<br>58642 Iserlohn<br>Germany | |
| Contact: | Mr. Frank Gischer<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] | |
| Prepared by: | Ms. Patricia Kontoudis<br>Senior Specialist, Regulatory Affairs<br>Regulatory and Quality Solutions, LLC<br>2790 Mosside Blvd., Suite 800<br>Monroeville, PA 15146<br>Phone: [phone]<br>[e-mail] | |
| Date Prepared: | March 4, 2021 | |
| Classification: | 21 CFR 872.3760 - Denture relining, repairing, or<br>rebasing resin | |
| Class: | II | |
| Product Codes: | EBI | |
| Primary Predicate Device: | NextDent Denture 3D+ (K191497) | |
| Additional Predicate: | Dentca Denture Base II (K162044) | |
| Reference Device: | Pro3dure GR-17 Resin System (K201827) | |

#### Indications for Use:

The GR-14.1 denture is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.1 denture is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

The GR-14.2 denture HI is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.2 denture HI is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

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### Device Description:

GR-14 Resin System includes the GR-14.1 denture and GR-14.2 denture HI and is made of functional methacrylic resins and inorganic fillers. It is available in three shades based on the shade guide, orange-pink, light-pink and deep-pink. The resin is a liquid photo-curable material that is polymerized by image projection systems at 405nm to create denture baseplates. The GR-14 Resin System is intended to be used in conjunction with an additive Computer- Aided Manufacturing (CAM) and curing system such as Nyomo, Rapidshape, Envisiontec or Asiga Systems. Preformed teeth are fixed into the denture base by extra gluing process with appropriate glue material.

#### Performance Testing:

Performance testing for the GR-14 Resin System was performed in accordance with ISO 20795-1 and ISO 22112, including Flexural Strength, Flexural modulus / Bending module, Bond Strength, Color Stability, Water Sorption and Solubility, Fracture toughness, and Total Work of Fracture Testing.

#### Biocompatibility:

Biocompatibility testing was conducted in accordance with ISO 10993-1.

### Shelf-Life:

The shelf life of the GR-14 Resin System is 2 year. Testing was performed in accordance with ASTM F1980-16.

| | Subject Device:<br>GR-14. Resin System | Predicate Device:<br>NextDent Denture 3D+ | Predicate Device:<br>Dentca Denture Base II |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Pro3dure Medical GmbH | Vertex-Dental BV | DENTCA, Inc. |
| 510(k) Number | K210298 | K191497 | K162044 |
| Indications for use | The GR-14.1 denture is a<br>light-curable polymerizable<br>resin intended to be used in<br>conjunction with extraoral<br>curing light equipment. The<br>GR-14.1 denture is indicated<br>for the fabrication and repair,<br>by additive manufacturing, of<br>full and partial removable<br>dentures and baseplates.<br><br>The GR-14.2 denture HI is a<br>light-curable polymerizable<br>resin intended to be used in<br>conjunction with extraoral<br>curing light equipment. The<br>GR-14.2 denture HI is | NextDent Denture 3D+<br>is a light-cured resin<br>indicated for the<br>fabrication of denture<br>bases fabricated in<br>dental laboratories,<br>including full and<br>partial removable<br>dentures. The material<br>is an alternative to<br>traditional heat cured<br>and auto<br>polymerization.<br>NextDent Denture 3D+<br>is intended exclusively<br>for professional dental<br>work. Fabrication of | DENTCA Denture<br>Base II is a light-<br>curable resin indicated<br>for the fabrication and<br>repair of full and partial<br>removable dentures and<br>baseplates. The<br>material is an<br>alternative to traditional<br>heat cured and auto<br>polymerization.<br>Fabrication of dental<br>prosthetics with Dentca<br>Denture Base II<br>requires a computer-<br>aided design and<br>manufacturing (CAD/ |

### Comparison to Predicate:

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| | Subject Device:<br>GR-14. Resin System | Predicate Device:<br>NextDent Denture 3D+ | Predicate Device:<br>Dentca Denture Base II |
|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Pro3dure Medical GmbH<br>indicated for the fabrication<br>and repair, by additive<br>manufacturing, of full and<br>partial removable dentures and<br>baseplates. | Vertex-Dental BV<br>denture bases with<br>NextDent Denture 3D+<br>requires a computer-<br>aided and<br>manufacturing<br>(CAD/CAM) system<br>that includes selected<br>scanner, design<br>software, additive<br>printer and post-cure<br>unit. | DENTCA, Inc.<br>CAM) system that<br>includes the following<br>components: digital<br>denture base files based<br>on a digital impression,<br>stereolithographic<br>additive printer, and<br>curing light equipment |
| | Comparison: The GR-14 Resin System has the same indications as the predicate devices. | | |
| Chemical<br>Description | Multifunctional<br>methacrylates/dimethacrylates,<br>inhibitors, stabilizers,<br>colors/pigments | Dimethacrylate-based<br>resin with photo-<br>initiator and pigments | Polymerizable<br>monomers |
| Comparison: The GR-14 Resin System has similar chemical characterization as the predicate devices. | | | |
| Curing Method | UV Light | UV Light | UV Light |
| | Comparison: The GR-14 Resin System uses the same curing method as the predicate devices. | | |
| Product State | Liquid | Liquid | Liquid |
| Comparison: The GR-14 Resin System and the predicate devices are provided in liquid form. | | | |
| Manufacturing | Additive | Additive | Additive |
| Comparison: The GR-14 Resin System and the predicate devices use additive manufacturing to<br>fabricate the final product. | | | |
| Performance<br>Standards | ISO 20795-1<br>ISO 22112 | ISO 20795-1 | ISO 20795-1 |
| Comparison: The GR-14 Resin System and the predicate devices comply with the same standards. | | | |
| Biocompatibility | ISO 7405<br>ISO 10993 | ISO 10993 | ISO 10993 |
| Comparison: The GR-14 Resin System and the predicate devices use biocompatible according to<br>the same standards. | | | |

### Conclusion:

The GR-14 Resin System is substantially equivalent in indications, technical characteristics, function, material. Performance, biocompatibility, and shelf life to the predicate devices.