The GR-17.1 temporary is indicated for the fabrication, by additive manufacturing, of temporary dental restorations, and for the fabrication, by additive manufacturing, of preformed denture teeth to be used in a denture.

Device Description

GR-17 Resin System includes the GR-17 temporary and GR-17.1 temporary It and is made of functional methacrylic resins and inorganic fillers with particle sizes from 0.4 to 3 microns. It is available in seven shades based on the shade guide, A1, A2, A3, A3.5, B1, B2 and bleach. The resin is a liquid photo-curable material that is polymerized by image projection systems at 405nm to create temporary dental restorations, and preformed denture teeth to be used in a denture. The GR-17 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.

AI/ML Overview

The provided document is a 510(k) summary for the GR-17 Resin System, a temporary crown and bridge resin. It describes the device's characteristics and compares it to predicate and reference devices to demonstrate substantial equivalence. However, this document does not contain the detailed information required to describe acceptance criteria and the study that proves the device meets those criteria, specifically concerning performance metrics for an AI/algorithm-based device.

The document mentions "Performance testing for the GR-17 Resin System was performed in accordance with ISO 10477 and ISO 22112" and lists "Flexural Strength," "Modulus of Elasticity," "Water Absorption," and "Solubility" as physical and mechanical properties. This indicates testing for the material properties of the resin itself, not the performance of an AI/algorithm-based device.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/algorithm, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies, as these types of studies are not described in this regulatory submission for a dental resin.

The document covers a physical medical device (dental resin) and not an AI/algorithm device. Therefore, the specific questions about AI/algorithm performance metrics, sample sizes for AI tests, expert adjudication, MRMC studies, and standalone performance for AI are not applicable to the content provided.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

November 5, 2020

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

Re: K201827

Trade/Device Name: GR-17 Resin System Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: Class II Product Code: EBG, PZY Dated: October 6, 2020 Received: October 7, 2020

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 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,

For Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201827

Device Name GR-17 Resin System

Indications for Use (Describe)

The GR-17 Resin System is a light-curable resin intended to be used in conjunction with extra-oral curing light equipment.

The GR-17 temporary is indicated for the fabrication, by additive manufacturing, of temporary anterior dental restorations.

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)

| X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Device Trade Name	GR-17 Resin System(GR-17 temporary and GR-17.1 temporary It)
Manufacturer	Pro3dure Medical GmbHAm Burgberg 1358642 IserlohnGermany
Contact	Dr. Martin KlarePhone: +49 (0)2374 920050-11Fax: +49 (0)2374 920050-50martin.klare@pro3dure.com
Prepared by	Ms. Patricia KontoudisSpecialist, Regulatory AffairsRegulatory and Quality Solutions, LLC2790 Mosside Blvd., Suite 800Monroeville, PA 15146Phone: (443)722-0126pkontoudis@rqteam.com
Date Prepared	November 5, 2020
Common Name	Crown and Bridge, Temporary, Resin
Classification Name	Temporary Crown and Bridge Resin
Regulation Number	21 CFR 872.3770
Regulatory Class	Class II
Product Codes	EBG
Subsequent Product Code	PZY
Primary Predicate Device	DeltaMed e-Dent Temporary Resin and Extra-OralCuring System (K102776)
Reference Device	Dentis Resin for Temporary Crown & Bridge(K180657)Dentca, Dentca Denture Teeth (K172398)

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Indications for Use	The GR-17 Resin System is a light-curablepolymerizable resin intended to be used inconjunction with extra-oral curing light equipment.The GR-17 temporary is indicated for the fabrication,by additive manufacturing, of temporary anteriordental restorations.The GR-17.1 temporary is indicated for thefabrication, by additive manufacturing, oftemporary dental restorations, and for thefabrication, by additive manufacturing, of preformeddenture teeth to be used in a denture.
Device Description	GR-17 Resin System includes the GR-17 temporaryand GR-17.1 temporary It and is made of functionalmethacrylic resins and inorganic fillers with particlesizes from 0.4 to 3 microns. It is available in sevenshades based on the shade guide, A1, A2, A3, A3.5,B1, B2 and bleach. The resin is a liquid photo-curable material that is polymerized by imageprojection systems at 405nm to create temporarydental restorations, and preformed denture teeth tobe used in a denture. The GR-17 Resin System isintended to be used in conjunction with an additiveComputer-Aided Manufacturing (CAM) and curingsystem such as Nyomo, Rapidshape, Envisiontec orAsiga Systems.
Performance Testing	Performance testing for the GR-17 Resin System wasperformed in accordance with ISO 10477 and ISO22112.
Biocompatibility	Biocompatibility testing was conducted inaccordance with ISO 10993-1.
Shelf Life	The shelf life of the GR-17 Resin System is 2 year.Testing was performed in accordance with ASTMF1980-16.

	GR-17 ResinSystem	Predicate Device:e-Dent TemporaryResin and Extra-Oral Curing System	Reference Device:Resin forTemporary Crown& Bridge	ReferenceDevice: DentcaDenture Teeth
Manufacturer	Pro3dure MedicalGmbH	DeltaMed GmbH	Dentis Co. Ltd.	Dentca, Inc.
510(k) Number	K201827	K102776	K180657	K172398
Indications for use	The GR-17 Resin System is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment. The GR-17 temporary is indicated for the fabrication, by additive manufacturing, of temporary anterior dental restorations. The GR-17.1 temporary It is indicated for the fabrication, by additive manufacturing, of temporary dental restorations, and for the fabrication, by additive manufacturing, of preformed denture teeth to be used in a denture.	The e-DENT TEMPORARY resin is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment.	Resin for Temporary Crown & Bridge is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment. Duration is less than 30 days in oral environment.	DENTCA Denture Teeth is a light-curable polymerizable resin to fabricate, by additive manufacturing, preformed denture teeth to be used in a denture.
Comparison: The GR-17 Resin System has similar indications as the predicate devices.
Chemical Description	Methacrylate- based resin	Methacrylate- based resin	Methacrylate- based resin	Methacrylate- based resin
Comparison: The GR-17 Resin System has similar chemical characterization as the predicate devices.
Acrylic Resin	Extra-oral light cure resin	Extra-oral light cure resin	Extra-oral light cure resin	Extra-oral light cure resin
Comparison: The GR-17 Resin System and the predicate devices are extra-oral light cure resins.
Curing Method	UV Light	UV Light	UV Light	UV Light
Comparison: The GR-17 Resin System uses the same curing method as the predicate devices.
Product State	Liquid	Liquid	Liquid	Liquid
Comparison: The GR-17 Resin System and the predicate devices are provided in liquid form.
Physical and Mechanical Properties	Flexural StrengthModulus of ElasticityWater AbsorptionSolubility	Flexural StrengthModulus of ElasticityWater AbsorptionSolubility	Not Available	Modulus of ElasticityWater AbsorptionSolubility
Comparison: The GR-17 Resin System and the predicate devices are equivalent physical and mechanical properties.
Manufacturing	Additive	Additive	Additive	Additive
Comparison: The GR-17 Resin System and the predicate devices use additive manufacturing to fabricate the final product.
Standards	ISO 10477ISO 22112ISO 4049	ISO 10477ISO 4049	ISO 10477	ISO 10477ISO 22112
Comparison: The GR-17 Resin System and the predicate devices comply with the same standards.
Biocompatibility	ISO 7405ISO 10993	ISO 10993	ISO 10993	ISO 7405ISO 10993
Comparison: The GR-17 Resin System and the predicate devices use biocompatible according to the same standards.

Comparison to Predicate

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Conclusion The GR-17 Resin System is substantially equivalent in indications, technical characteristics, function, material, performance, biocompatibility, and shelf life to the predicate and reference devices.

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.