(126 days)
No
The summary describes a resin system used in additive manufacturing (3D printing) for dental restorations. While it mentions "image projection systems" and "Computer-Aided Manufacturing (CAM)", there is no mention of AI, ML, or any related concepts like training sets, test sets, or performance metrics typically associated with AI/ML algorithms. The focus is on the material properties and the manufacturing process.
No
The device is a material (resin) used to fabricate temporary dental restorations and denture teeth; it does not directly perform a therapeutic function itself.
No
The GR-17 Resin System is a resin used for fabricating temporary dental restorations and denture teeth, not for diagnosing medical conditions.
No
The device is a resin system, which is a physical material used in additive manufacturing, not a software program.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the GR-17 Resin System is used for fabricating temporary dental restorations and preformed denture teeth. These are physical devices placed in the mouth, not used to analyze biological samples.
- The device description focuses on the material properties and fabrication process. It describes the resin's composition, curing mechanism, and compatibility with additive manufacturing systems. This is consistent with a material used for creating medical devices, not for diagnostic testing.
- The performance studies mentioned are related to material standards (ISO 10477 and ISO 22112). These standards are relevant to dental materials and their physical properties, not to the performance of a diagnostic test.
- There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information. The device's function is to create a physical restoration.
In summary, the GR-17 Resin System is a material used in the fabrication of dental prosthetics, which are considered medical devices, but not IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
EBG, PZY
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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Temporary anterior dental restorations, temporary dental restorations, preformed denture teeth (to be used in a denture).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance testing for the GR-17 Resin System was performed in accordance with ISO 10477 and ISO 22112.
Biocompatibility testing was conducted in accordance with ISO 10993-1.
The shelf life of the GR-17 Resin System is 2 year. Testing was performed in accordance with ASTM F1980-16.
Key Metrics
Not Found
Predicate Device(s)
DeltaMed e-Dent Temporary Resin and Extra-Oral Curing System (K102776)
Reference Device(s)
Dentis Resin for Temporary Crown & Bridge (K180657), Dentca, Dentca Denture Teeth (K172398)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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.
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) | |
|---|---|
| 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 GmbH
Am Burgberg 13
58642 Iserlohn
Germany |
| Contact | Dr. Martin Klare
Phone: +49 (0)2374 920050-11
Fax: +49 (0)2374 920050-50
martin.klare@pro3dure.com |
| Prepared by | Ms. Patricia Kontoudis
Specialist, Regulatory Affairs
Regulatory and Quality Solutions, LLC
2790 Mosside Blvd., Suite 800
Monroeville, PA 15146
Phone: (443)722-0126
pkontoudis@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-Oral
Curing 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-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 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. |
| Performance Testing | Performance testing for the GR-17 Resin System was
performed in accordance with ISO 10477 and ISO
22112. |
| Biocompatibility | Biocompatibility testing was conducted in
accordance with ISO 10993-1. |
| Shelf Life | The shelf life of the GR-17 Resin System is 2 year.
Testing was performed in accordance with ASTM
F1980-16. |
| | GR-17 Resin
System | Predicate Device:
e-Dent Temporary
Resin and Extra-
Oral Curing System | Reference Device:
Resin for
Temporary Crown
& Bridge | Reference
Device: Dentca
Denture Teeth |
|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Pro3dure Medical
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
Modulus of Elasticity
Water Absorption
Solubility | Flexural Strength
Modulus of Elasticity
Water Absorption
Solubility | Not Available | Modulus of Elasticity
Water Absorption
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
ISO 22112
ISO 4049 | ISO 10477
ISO 4049 | ISO 10477 | ISO 10477
ISO 22112 |
| Comparison: The GR-17 Resin System and the predicate devices comply with the same standards. | | | | |
| Biocompatibility | ISO 7405
ISO 10993 | ISO 10993 | ISO 10993 | ISO 7405
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.