(168 days)
No
The summary describes a resin system for additive manufacturing of dental appliances and does not mention any AI or ML components.
No.
The device is a light-curable resin system used to fabricate dental and orthodontic objects like splints, mouthguards, nightguards, repositioners, and retainers. It is a material for manufacturing, not a therapeutic device itself.
No
This device is a resin system used for the fabrication of orthodontic and dental objects. It does not perform any diagnostic function. Its purpose is to create physical devices, not to diagnose conditions.
No
The device description clearly states that the device is a "light-curable resin" and is a "liquid photo-curable material," indicating it is a physical substance, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the GR Splint Resin System is for the "fabrication, by additive manufacturing, of orthodontic and dental objects such as splints, mouthguards, nightguards, repositioners and retainers." This describes a material used to create physical dental appliances.
- Device Description: The description details the composition of the resin and how it is polymerized to create these dental appliances.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on biological samples to gain information about a patient's health status. This device is a material used to create a physical device that is then placed in the patient's mouth.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MQC, EBI, KMY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Orthodontic and dental objects
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
KeyPrint KeySplint Hard (K203000), KeyPrint KeySplint Soft (K183598)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Pro3dure GR-17 Resin System (K201827)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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
1
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
2
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 GmbH
Am Burgberg 13
58642 Iserlohn
Germany | Manufacturer | Pro3dure Medical GmbH | Mycone Dental Supply Co. Inc. | Keystone Industries |
| Contact: | Mr. Frank Gischer
Phone: +49 (0)2374 920050-14
Fax: +49 (0)2374 920050-50
Frank.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 Kontoudis
Senior Specialist, Regulatory Affairs
Regulatory and Quality Solutions, LLC
2790 Mosside Blvd., Suite 800
Monroeville, PA 15146
Phone: (443)722-0126
pkontoudis@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 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 | 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 20795-2
ASTM D256
ISO 37 | ISO 20795-2
ASTM D256
ISO 37 | ISO 20795-2
ASTM D256
ISO 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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5
Comparison to Predicate Devices:
6
Conclusion: The GR Splint Resin System is substantially equivalent in indications, technical characteristics, function, material, performance, biocompatibility, and shelf life to the predicate devices.