The GR-19 OA is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, repositioners and retainers.

The GR-22 flex is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, and repositioners.

Device Description

GR Splint Resin System includes the GR-10 Guide Resin, GR-19 OA Resin, and GR-22 flex Resin. The GR Splint Resin System is made of functional methacrylic resins and inorganic fillers.

The GR-10 Guide Resin, GR-19 OA Resin, GR-22 flex Resin It is available in light blue-transparent, clear transparent and rose-transparent shades. The resin is a liquid photo-curable material that is polymerized by image projection systems at 385 nm and 405 nm to create dental appliances. The GR-10 Guide Resin, GR-19 OA Resin, GR-22 flex Resin are 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 document describes the GR Splint Resin System, a light-curable resin for fabricating orthodontic and dental objects. It references its substantial equivalence to predicate devices based on performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that performance testing for the GR Splint Resin System was performed in accordance with ISO 20795-2. This standard specifies requirements and test methods for denture base polymers. The specific tests performed and their respective acceptance criteria and reported device performance are not explicitly detailed in a comparative table within the provided text. However, the document lists the measured parameters:

Acceptance Criteria (Governing Standard)	Reported Device Performance (Measurements Performed)
ISO 20795-2 (General standard for denture base polymers)	- Flexural Strength
	- Flexural Modulus / Bending Modulus
	- Water Sorption and Solubility
	- Fracture Toughness
	- Total Work of Fracture Testing
	- Tensile Strength
	- Elongation at Break
ASTM D256 (Standard test methods for determining the Izod pendulum impact resistance of plastics)	- Not explicitly detailed, but implied by compliance with ASTM D256.
ISO 37 (Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties)	- Not explicitly detailed, but implied by compliance with ISO 37.
ISO 10993-1 (Biocompatibility testing)	- Biocompatibility
ASTM F1980-16 (Standard guide for accelerated aging of sterile medical device packages)	- Shelf-life of 2 years

The document states, "Performance testing for the GR Splint Resin System was performed in accordance with ISO 20795-2 including Flexural Strength, Flexural modulus / Bending module, Water Sorption and Solubility, Fracture toughness, Total Work of Fracture Testing, Tensile Strength, and Elongation at Break." It also notes that the subject and predicate devices "comply with the same performance standards" and undergo the same biocompatibility and shelf-life testing. However, the specific numerical results of these tests for the GR Splint Resin System and the predicate devices are not provided in this excerpt.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the performance testing or provide details on the data provenance (e.g., country of origin, retrospective or prospective). It only mentions that "Performance testing for the GR Splint Resin System was performed in accordance with ISO 20795-2".

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable. The device is a material (resin) and not an AI/diagnostic device that would require expert-established ground truth for a test set. The "testing" refers to physical, mechanical, and chemical properties of the material.

4. Adjudication Method

This information is not applicable as the testing does not involve human interpretation or adjudication in the context of diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. The device is a material, not an AI system or diagnostic tool that would be evaluated in a MRMC study.

6. Standalone (Algorithm Only) Performance

This information is not applicable as the device is a material, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance "study" in this context is established by the specified international and national standards (e.g., ISO 20795-2, ASTM D256, ISO 37, ISO 10993-1, ASTM F1980-16). The material's physical, mechanical, and biocompatibility properties are measured against the requirements set forth in these standards.

8. Sample Size for the Training Set

This information is not applicable. The device is a material, not an AI model that requires a training set. The manufacturing process of the resin would involve formulation and quality control, but not a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

Summary

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Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 21, 2021

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

Re: K211415

Trade/Device Name: GR Splint Resin System Regulatory Class: Unclassified Product Code: MQC, EBI, KMY Dated: August 9, 2021 Received: August 25, 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 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

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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 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 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) K211415

Device Name GR Splint Resin System

Indications for Use (Describe)

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

The GR-10 guide is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as splints.

The GR-19 OA is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, repositioners and retainers.

The GR-22 flex is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, and repositioners.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K211415 5. 510(k) Summary

Device Trade Name:	GR Splint Resin System	Device	Subject Device	Primary Predicate Device:KeyPrint KeySplint Hard(K203000)	Additional Predicate Device:KeyPrint KeySplint Soft(K183598)
Manufacturer:	Pro3dure Medical GmbHAm Burgberg 1358642 IserlohnGermany	Manufacturer	Pro3dure Medical GmbH	Mycone Dental Supply Co. Inc.	Keystone Industries
Contact:	Mr. Frank GischerPhone: +49 (0)2374 920050-14Fax: +49 (0)2374 920050-50Frank.gischer@pro3dure.com	Indications for use	The GR Splint Resin System is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment:The GR-10 guide is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as splints.The GR-19 OA is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, repositioners and retainers.The GR-22 flex is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, and repositioners.	KeyPrint® KeySplint Hard™ is a biocompatible photopolymer resin intended for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers	The KeyPrint® KeySplint Soft™ device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.
Prepared by:	Ms. Patricia KontoudisSenior Specialist, Regulatory AffairsRegulatory and Quality Solutions, LLC2790 Mosside Blvd., Suite 800Monroeville, PA 15146Phone: (443)722-0126pkontoudis@rqmplus.com	Comparison: The subject and the predicate devices have the same indications.
Date Prepared:	April 30, 2021	Chemical Description	Methacrylate Monomers, photo initiator	Contains acrylate monomers and oligomers, photo initiator	Contains acrylate monomers and oligomers, photo initiator
Classification:	Unclassified	Comparison: The subject and the predicate devices have similar chemical characterization.
Product Codes:	MQC	Manufacturing Technology	Additive	Additive	Additive
Additional Product Codes:	EBI, KMY	Comparison: The subject and the predicate devices use additive manufacturing to fabricate the final product.
Primary Predicate Device:	KeyPrint KeySplint Hard (K203000)	Product State	Liquid	Liquid	Liquid
Additional Predicate:	KeyPrint KeySplint Soft (K183598)	Comparison: The subject and the predicate devices are provided in liquid form.
Reference Device:	Pro3dure GR-17 Resin System (K201827)	Curing Method	UV Light	UV Light	UV Light
Indications for Use:	The GR Splint Resin System is a light-curable polymerizableresin intended to be used in conjunction with extra-oralcuring light equipment:The GR-10 guide is indicated for the fabrication, by additivemanufacturing, of orthodontic and dental objects such assplints.The GR-19 OA is indicated for the fabrication, by additivemanufacturing, of orthodontic and dental objects such as	Comparison: The subject and the predicate devices use the same curing method.
Device Description:	mouthguards, nightguards, splints, repositioners and retainers.The GR-22 flex is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, nightguards, splints, and repositioners.GR Splint Resin System includes the GR-10 Guide Resin, GR-19 OA Resin, and GR-22 flex Resin. The GR Splint Resin System is made of functional methacrylic resins and inorganic fillers.The GR-10 Guide Resin, GR-19 OA Resin, GR-22 flex Resin It is available in light blue-transparent, clear transparent and rose-transparent shades. The resin is a liquid photo-curable material that is polymerized by image projection systems at 385 nm and 405 nm to create dental appliances. The GR-10 Guide Resin, GR-19 OA Resin, GR-22 flex Resin are intended to be used in conjunction with an additive Computer-Aided Manufacturing (CAM) and curing system such as Nyomo, Rapidshape, Envisiontec or Asiga Systems.	Performance Testing	ISO 20795-2ASTM D256ISO 37	ISO 20795-2ASTM D256ISO 37	ISO 20795-2ASTM D256ISO 37
Performance Testing:	Performance testing for the GR Splint Resin System was performed in accordance with ISO 20795-2 including Flexural Strength, Flexural modulus / Bending module, Water Sorption and Solubility, Fracture toughness, Total Work of Fracture Testing, Tensile Strength, and Elongation at Break.	Comparison: The subject and the predicate devices comply with the same performance standards.
Biocompatibility:	Biocompatibility testing was conducted in accordance with ISO 10993-1.	Biocompatibility	ISO 10993	ISO 10993	ISO 10993
Shelf-Life:	The shelf life of the GR Splint Resin System is 2 years. Testing was performed in accordance with ASTM F1980-16

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Comparison to Predicate Devices:

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

Regulation Number and Section

N/A