GR-17 Resin System

K201827 · Pro3Dure Medical GmbH · EBG · Nov 5, 2020 · Dental

Device Facts

• Record ID: K201827
• Device Name: GR-17 Resin System
• Applicant: Pro3Dure Medical GmbH
• Product Code: EBG · Dental
• Decision Date: Nov 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 Story

GR-17 Resin System consists of light-curable methacrylic resins with inorganic fillers (0.4-3 microns); available in seven shades. Liquid resin polymerized via 405nm image projection systems (additive manufacturing/CAM systems like Nyomo, Rapidshape, Envisiontec, or Asiga). Used in dental clinics/labs by professionals to fabricate temporary dental restorations and denture teeth. Output is a physical dental prosthetic. Benefits include efficient, customized fabrication of temporary restorations and denture components.

Clinical Evidence

Bench testing only. Performance testing conducted per ISO 10477 and ISO 22112. Biocompatibility testing conducted per ISO 10993-1. Shelf life testing performed per ASTM F1980-16.

Technological Characteristics

Methacrylate-based resin with inorganic fillers (0.4-3 microns). Curing via 405nm UV light projection. Complies with ISO 10477, ISO 22112, ISO 4049, and ISO 10993. Liquid form factor.

Indications for Use

Indicated for fabrication of temporary anterior dental restorations (GR-17 temporary) and temporary dental restorations or preformed denture teeth (GR-17.1 temporary) via additive manufacturing.

Regulatory Classification

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.

Predicate Devices

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

Reference Devices

• Dentis Resin for Temporary Crown & Bridge (K180657)
• Dentca, Dentca Denture Teeth (K172398)

Submission Summary (Full Text)

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

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg height="16" width="16"> <polygon points="0,0 0,16 16,16 16,0" style="fill:none;stroke:black;stroke-width:1"></polygon> <polyline points="2,8 6,12 14,4" style="fill:none;stroke:black;stroke-width:2"></polyline> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg height="16" width="16"> <polygon points="0,0 0,16 16,16 16,0" style="fill:none;stroke:black;stroke-width:1"></polygon> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

| 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<br>(GR-17 temporary and GR-17.1 temporary It) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Pro3dure Medical GmbH<br>Am Burgberg 13<br>58642 Iserlohn<br>Germany |
| Contact | Dr. Martin Klare<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Prepared by | Ms. Patricia Kontoudis<br>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 | 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-Oral<br>Curing System (K102776) |
| Reference Device | Dentis Resin for Temporary Crown & Bridge<br>(K180657)<br>Dentca, Dentca Denture Teeth (K172398) |

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| Indications for Use | The GR-17 Resin System is a light-curable<br>polymerizable resin intended to be used in<br>conjunction with extra-oral curing light equipment.<br><br>The GR-17 temporary is indicated for the fabrication,<br>by additive manufacturing, of temporary anterior<br>dental restorations.<br><br>The GR-17.1 temporary is indicated for the<br>fabrication, by additive manufacturing, of<br>temporary dental restorations, and for the<br>fabrication, by additive manufacturing, of preformed<br>denture teeth to be used in a denture. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | GR-17 Resin System includes the GR-17 temporary<br>and GR-17.1 temporary It and is made of functional<br>methacrylic resins and inorganic fillers with particle<br>sizes from 0.4 to 3 microns. It is available in seven<br>shades based on the shade guide, A1, A2, A3, A3.5,<br>B1, B2 and bleach. The resin is a liquid photo-<br>curable material that is polymerized by image<br>projection systems at 405nm to create temporary<br>dental restorations, and preformed denture teeth to<br>be used in a denture. The GR-17 Resin System is<br>intended to be used in conjunction with an additive<br>Computer-Aided Manufacturing (CAM) and curing<br>system such as Nyomo, Rapidshape, Envisiontec or<br>Asiga Systems. |
| Performance Testing | Performance testing for the GR-17 Resin System was<br>performed in accordance with ISO 10477 and ISO<br>22112. |
| Biocompatibility | Biocompatibility testing was conducted in<br>accordance with ISO 10993-1. |
| Shelf Life | The shelf life of the GR-17 Resin System is 2 year.<br>Testing was performed in accordance with ASTM<br>F1980-16. |

| | GR-17 Resin<br>System | Predicate Device:<br>e-Dent Temporary<br>Resin and Extra-<br>Oral Curing System | Reference Device:<br>Resin for<br>Temporary Crown<br>& Bridge | Reference<br>Device: Dentca<br>Denture Teeth |
|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Pro3dure Medical<br>GmbH | 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 Strength<br>Modulus of Elasticity<br>Water Absorption<br>Solubility | Flexural Strength<br>Modulus of Elasticity<br>Water Absorption<br>Solubility | Not Available | Modulus of Elasticity<br>Water Absorption<br>Solubility |
| 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 10477<br>ISO 22112<br>ISO 4049 | ISO 10477<br>ISO 4049 | ISO 10477 | ISO 10477<br>ISO 22112 |
| Comparison: The GR-17 Resin System and the predicate devices comply with the same standards. | | | | |
| Biocompatibility | ISO 7405<br>ISO 10993 | ISO 10993 | ISO 10993 | ISO 7405<br>ISO 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.