(419 days)
The printodent® GR-10 guide | MSI is a light-curable resin intended to be used in conjunction with extraoral curing light equipment for the fabrication, by additive manufacturing, of orthodontic and dental objects such as splints.
The printodent® GR-19.1 OA is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, splints, repositioners and retainers.
The printodent® GR-19.1 OA | MSI is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, nightguards, splints, repositioners and retainers.
The printodent® GR-19.1 OA | MSI is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, nightguards, splints, repositioners and retainers.
GR-10 guide MSI is made of functional methacrylic resins and inorganic fillers and the GR-19.1 OA, and GR-19.1 OA MSI consist of functional (meth)acrylic resins, initiators, dyes, stabilisers and lactam.
The GR-10 guide MSI, and GR-19.1 OA MSI are available in ocean blue shade, and the GR-19.1 OA is available in clear transparent. The resin is a liquid photo-curable material that is polymerized by image projection systems at ≤ 405 nm to create dental appliances. The GR Resin System MSI 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
The provided text describes a 510(k) premarket notification for a GR Resin System MSI, a light-curable polymerizable resin used for fabricating orthodontic and dental objects. However, it does not contain information about a study proving the device meets acceptance criteria related to artificial intelligence (AI) performance, human reader improvement with AI assistance (MRMC), or standalone algorithm performance.
This document focuses on demonstrating substantial equivalence to predicate devices based on indications for use, chemical composition, manufacturing technology, physical state, curing method, and compliance with performance, biocompatibility, and shelf-life standards. The "Performance Testing" section only states that testing was performed in accordance with ISO 20795-2 for Flexural Strength, Flexural modulus / Bending module, Water Sorption, and Solubility.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/human-in-the-loop device, as the provided text pertains to a different type of medical device (a dental resin).
To answer your request, I would need a document describing the study and acceptance criteria for an AI-powered medical device.
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August 8, 2024
Pro3dure Medical % Patricia Kontoudis Regulatory Affairs Specialist Kontoudis Regulatory Consulting, LLC 804 Umbra St. Baltimore, Maryland 21224
Re: K231775
Trade/Device Name: GR Resin System MSI Regulatory Class: Unclassified Product Code: MQC, KMY Dated: June 10, 2024 Received: June 11, 2024
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA 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) K231775
Device Name GR Resin System MSI
Indications for Use (Describe)
The printodent® GR-10 guide | MSI is a light-curable resin intended to be used in conjunction with extraoral curing light equipment for the fabrication, by additive manufacturing, of orthodontic and dental objects such as splints.
The printodent® GR-19.1 OA is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, splints, repositioners and retainers.
The printodent® GR-19.1 OA | MSI is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, nightguards, splints, repositioners and retainers.
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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K231775
6. 510(k) Summary
| Device Trade Name: | GR Resin System MSI |
|---|---|
| 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 KontoudisRegulatory AffairsSpecialistKontoudis Regulatory Consulting,LLC 804 Umbra StreetBaltimore, MD 21224Phone: (443)722-0126Email: tricia@kontoudisconsulting.com |
| Date Prepared: | June 10, 2024 |
| Classification: | Unclassified |
| Product Codes: | MQC |
| Additional Product Codes: | KMY |
| Primary Predicate Device: | GR Splint Resin System (K211415) |
| Additional Predicates: | KeyPrint KeySplint hard (K203000)KeyPrint KeySplint Soft (K183598) |
| Reference Device: | Pro3dure GR-17 Resin System (K201827) |
| Indications for Use: | The printodent® GR-10 guide MSI is a light-curablepolymerizable resin intended to be used in conjunction withextra-oral curing light equipment for the fabrication, byadditive manufacturing, of orthodontic and dental objectssuch as splints.The printodent® GR-19.1 OA is a light-curablepolymerizable resin intended to be used in conjunction withextra-oral curing light equipment for the fabrication, byadditive manufacturing, of dental objects such asmouthguards, nightguards, splints, repositioners and |
| Device Description: | The printodent® GR-19.1 OA MSI is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, nightguards, splints, repositioners and retainers.GR-10 guide MSI is made of functional methacrylic resins and inorganic fillers and the GR-19.1 OA, and GR-19.1 OA MSI consist of functional (meth)acrylic resins, initiators, dyes, stabilisers and lactam.The GR-10 guide MSI, and GR-19.1 OA MSI are available in ocean blue shade, and the GR-19.1 OA is available in clear transparent. The resin is a liquid photo-curable material that is polymerized by image projection systems at ≤ 405 nm to create dental appliances. The GR Resin System MSI 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 Resin System MSI was performed in accordance with ISO 20795-2 including Flexural Strength, and Flexural modulus / Bending module, Water Sorption and Solubility. |
| Biocompatibility: | Biocompatibility testing was conducted in accordance with ISO 10993-1. |
| Shelf-Life: | The shelf life of the GR Resin System MSI is 2 years. Testing was performed in accordance with ASTM F1980-16. |
retainers.
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| Device | Subject Device: | PrimaryPredicateDevice:GR Splint ResinSystem (K211415) | AdditionalPredicateDevice:KeyPrintKeySplintHard(K203000) | AdditionalPredicate Device:KeyPrint KeySplintSoft(K183598) |
|---|---|---|---|---|
| Manufacturer | Pro3dureMedicalGmbH | Pro3dure MedicalGmbH | Mycone DentalSupply Co. Inc. | Mycone DentalSupply Co. Inc. |
| Indications for use | The printodent®GR-10 guide MSIis a light-curablepolymerizableresin intended to beused in conjunctionwith extra-oralcuring lightequipment for thefabrication, byadditivemanufacturing, oforthodontic anddental objects suchas splints.The printodent®GR-19.1 OA is alight-curablepolymerizableresin intended to beused in conjunctionwith extra-oralcuring lightequipment for thefabrication, byadditivemanufacturing, ofdental objects suchas mouthguards,nightguards,splints,repositioners andretainers.The printodent®GR-19.1 OA MSIis a light-curablepolymerizableresin intended to beused in conjunctionwith extra-oralcuring lightequipment for thefabrication, byadditivemanufacturing, ofdental objects suchas mouthguards,nightguards,splints,repositioners andretainers | The GR SplintResin System is alight-curablepolymerizableresin intended to beused in conjunctionwith extra-oralcuring lightequipment:The GR-10guide isindicated forthe fabrication,by additivemanufacturing,of orthodonticand dentalobjects such assplints.The GR-19 OA isindicated for thefabrication, byadditivemanufacturing, oforthodontic anddental objects suchas nightguards,splints,repositioners andretainers.The GR-22 flex isindicated for thefabrication, byadditivemanufacturing, oforthodontic anddental objectssuch asmouthguards,nightguards,splints, andrepositioners. | KeyPrint®KeySplint Hard™is a biocompatiblephotopolymerresin intended forthe fabrication oforthodontic anddental appliancessuch asmouthguards,nightguards,splints.repositioners, andretainers | The KeyPrint®KeySplint Soft™device is indicatedfor the fabrication oforthodontic anddental appliancessuch asmouthguards,nightguards,splints andrepositioners. |
| Comparison: The subject and the predicate devices have the same indications. | ||||
| Chemical Description | MethacrylateMonomers, photoinitiator | Contains acrylatemonomers andoligomers, photoinitiator | Contains acrylatemonomers andoligomers, photoinitiator | Contains acrylatemonomers andoligomers, photoinitiator |
| Comparison: The subject and the predicate devices have similar chemical characterization. | ||||
| Manufacturing Technology | Additive | Additive | Additive | Additive |
| Comparison: The subject and the predicate devices use additive manufacturing to fabricate the final product. | ||||
| Product State | Liquid | Liquid | Liquid | Liquid |
| Comparison: The subject and the predicate devices are provided in liquid form. | ||||
| Curing Method | UV Light | UV Light | UV Light | UV Light |
| Comparison: The subject and the predicate devices use the same curing method. | ||||
| Performance Testing | ISO 20795-2 | ISO 20795-2 | ISO 20795-2 | ISO 20795-2 |
| Comparison: The subject and the predicate devices comply with the same performance standards. | ||||
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | ISO 10993 |
| Comparison: The subject and the predicate devices comply with the same biocompatible standards. |
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Conclusion:
The GR Resin System MSI is substantially equivalent in indications, technical characteristics, function, material, performance, biocompatibility, and shelf life to the predicate devices.
N/A