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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: GR-14 Resin System (GR-14.1 denture and GR-14.2 denture HI)

Intended Use: Light-curable polymerizable resin for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with numerical targets for each performance standard. Instead, it states that performance testing was performed in accordance with specific ISO standards. This implies that meeting the requirements specified within these standards constitutes the acceptance criteria. The "Reported Device Performance" column therefore reflects that the device successfully met these standards, as a conclusion of "substantial equivalence" is drawn.

Acceptance Criteria (Standards followed)	Reported Device Performance
Performance Testing
ISO 20795-1 (Dentistry - Base polymers - Part 1: Denture base polymers)	Performed in accordance with ISO 20795-1, indicating compliance with requirements for: - Flexural Strength - Flexural modulus / Bending module - Bond Strength - Color Stability - Water Sorption and Solubility - Fracture toughness - Total Work of Fracture Testing
ISO 22112 (Dentistry - Artificial teeth for dental prostheses)	Performed in accordance with ISO 22112, indicating compliance with requirements relevant to the resin system's properties for denture bases.
Biocompatibility
ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process)	Biocompatibility testing conducted in accordance with ISO 10993-1, indicating the device is biocompatible.
Shelf-Life
ASTM F1980-16 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages)	Shelf life of 2 years demonstrated through testing in accordance with ASTM F1980-16.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample sizes used for the test sets in the performance, biocompatibility, or shelf-life studies. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The studies mentioned (performance, biocompatibility, shelf-life) are technical tests on material properties, not diagnostic studies requiring expert interpretation of results to establish "ground truth" in the way it's typically understood for AI/diagnostic devices.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. The acceptance criteria are based on defined standards and physical/chemical testing, not on adjudicated expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and the study aims to assess the impact of AI assistance on their performance. The GR-14 Resin System is a material used for manufacturing dentures, not a diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

This concept is not applicable to the GR-14 Resin System. This device is a material, not an algorithm. The performance tests are inherently "standalone" in that they evaluate the material's properties directly, not its interaction with a human operator beyond proper manufacturing and curing processes.

7. The Type of Ground Truth Used:

For the performance testing, the "ground truth" is defined by the specifications and limits within the cited ISO and ASTM standards. For example, flexural strength must meet a certain value specified in ISO 20795-1. For biocompatibility, the ground truth is simply whether the material passes the tests outlined in ISO 10993-1, indicating it does not elicit adverse biological reactions.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. The GR-14 Resin System is a material, not an AI/machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable and therefore not provided, as there is no training set for this type of device.

Summary

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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 (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 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)

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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5. 510(k) Summary - K210298

Device Trade Name:	GR-14 Resin System
Manufacturer:	Pro3dure Medical GmbHAm Burgberg 1358642 IserlohnGermany
Contact:	Mr. Frank GischerPhone: +49 (0)2374 920050-14Fax: +49 (0)2374 920050-50frank.gischer@pro3dure.com
Prepared by:	Ms. Patricia KontoudisSenior Specialist, Regulatory AffairsRegulatory and Quality Solutions, LLC2790 Mosside Blvd., Suite 800Monroeville, PA 15146Phone: (443)722-0126pkontoudis@rqteam.com
Date Prepared:	March 4, 2021
Classification:	21 CFR 872.3760 - Denture relining, repairing, orrebasing 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:

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:GR-14. Resin System	Predicate Device:NextDent Denture 3D+	Predicate Device: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 alight-curable polymerizableresin intended to be used inconjunction with extraoralcuring light equipment. TheGR-14.1 denture is indicatedfor the fabrication and repair,by additive manufacturing, offull and partial removabledentures and baseplates.The GR-14.2 denture HI is alight-curable polymerizableresin intended to be used inconjunction with extraoralcuring light equipment. TheGR-14.2 denture HI is	NextDent Denture 3D+is a light-cured resinindicated for thefabrication of denturebases fabricated indental laboratories,including full andpartial removabledentures. The materialis an alternative totraditional heat curedand autopolymerization.NextDent Denture 3D+is intended exclusivelyfor professional dentalwork. Fabrication of	DENTCA DentureBase II is a light-curable resin indicatedfor the fabrication andrepair of full and partialremovable dentures andbaseplates. Thematerial is analternative to traditionalheat cured and autopolymerization.Fabrication of dentalprosthetics with DentcaDenture Base IIrequires a computer-aided design andmanufacturing (CAD/

Comparison to Predicate:

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	Subject Device:GR-14. Resin System	Predicate Device:NextDent Denture 3D+	Predicate Device:Dentca Denture Base II
Manufacturer	Pro3dure Medical GmbHindicated for the fabricationand repair, by additivemanufacturing, of full andpartial removable dentures andbaseplates.	Vertex-Dental BVdenture bases withNextDent Denture 3D+requires a computer-aided andmanufacturing(CAD/CAM) systemthat includes selectedscanner, designsoftware, additiveprinter and post-cureunit.	DENTCA, Inc.CAM) system thatincludes the followingcomponents: digitaldenture base files basedon a digital impression,stereolithographicadditive printer, andcuring light equipment
	Comparison: The GR-14 Resin System has the same indications as the predicate devices.
ChemicalDescription	Multifunctionalmethacrylates/dimethacrylates,inhibitors, stabilizers,colors/pigments	Dimethacrylate-basedresin with photo-initiator and pigments	Polymerizablemonomers
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 tofabricate the final product.
PerformanceStandards	ISO 20795-1ISO 22112	ISO 20795-1	ISO 20795-1
Comparison: The GR-14 Resin System and the predicate devices comply with the same standards.
Biocompatibility	ISO 7405ISO 10993	ISO 10993	ISO 10993
Comparison: The GR-14 Resin System and the predicate devices use biocompatible according tothe 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.

Regulation Number and Section

§ 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.