(91 days)
No
The document describes a resin system for 3D printing dentures and mentions its use with CAM systems, but there is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is a light-curable resin system used to create and repair dentures and baseplates, which are prosthetic devices, not therapeutic.
No
Explanation: The device is a resin used for manufacturing and repairing dentures, not for diagnosing medical conditions. Its function is to create a physical product.
No
The device is a resin material used in additive manufacturing of dentures, which is a physical product, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the fabrication and repair of full and partial removable dentures and baseplates. This is a mechanical/structural application, not a diagnostic one.
- Device Description: The description focuses on the material properties and how it's used in additive manufacturing to create physical denture components.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It doesn't analyze biological samples or provide information for diagnosis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The GR-14.1 denture is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.1 denture is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.
The GR-14.2 denture HI is a light-curable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.2 denture HI is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
GR-14 Resin System includes the GR-14.1 denture and GR-14.2 denture HI and is made of functional methacrylic resins and inorganic fillers. It is available in three shades based on the shade guide, orange-pink, light-pink and deep-pink. The resin is a liquid photo-curable material that is polymerized by image projection systems at 405nm to create denture baseplates. The GR-14 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. Preformed teeth are fixed into the denture base by extra gluing process with appropriate glue material.
Mentions image processing
The resin is a liquid photo-curable material that is polymerized by image projection systems at 405nm to create denture baseplates.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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-14 Resin System was performed in accordance with ISO 20795-1 and ISO 22112, including Flexural Strength, Flexural modulus / Bending module, Bond Strength, Color Stability, Water Sorption and Solubility, Fracture toughness, and Total Work of Fracture Testing.
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.
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.
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
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
May 5, 2021
Pro3dure Medical GmbH % Patricia Kontoudis Senior Specialist, Regulatory Affairs Regulatory and Quality Solutions, LLC 2790 Mosside Blvd., Suite 800 Monroeville, Pennsylvania 15146
Re: K210298
Trade/Device Name: GR-14 Resin System Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: March 4, 2021 Received: March 9, 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
1
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 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 medical devices and radiation-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) K210298
Device Name GR-14 Resin System
Indications for Use (Describe)
The GR-14.1 denture is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.1 denture is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.
The GR-14.2 denture HI is a light-curable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.2 denture HI is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.
| 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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3
5. 510(k) Summary - K210298
| Device Trade Name: | GR-14 Resin System | |
|---|---|---|
| Manufacturer: | Pro3dure Medical GmbH | |
| Am Burgberg 13 | ||
| 58642 Iserlohn | ||
| Germany | ||
| Contact: | Mr. Frank Gischer | |
| Phone: +49 (0)2374 920050-14 | ||
| Fax: +49 (0)2374 920050-50 | ||
| frank.gischer@pro3dure.com | ||
| 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@rqteam.com | ||
| Date Prepared: | March 4, 2021 | |
| Classification: | 21 CFR 872.3760 - Denture relining, repairing, or | |
| rebasing resin | ||
| Class: | II | |
| Product Codes: | EBI | |
| Primary Predicate Device: | NextDent Denture 3D+ (K191497) | |
| Additional Predicate: | Dentca Denture Base II (K162044) | |
| Reference Device: | Pro3dure GR-17 Resin System (K201827) |
Indications for Use:
The GR-14.1 denture is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.1 denture is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.
The GR-14.2 denture HI is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. The GR-14.2 denture HI is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.
4
Device Description:
GR-14 Resin System includes the GR-14.1 denture and GR-14.2 denture HI and is made of functional methacrylic resins and inorganic fillers. It is available in three shades based on the shade guide, orange-pink, light-pink and deep-pink. The resin is a liquid photo-curable material that is polymerized by image projection systems at 405nm to create denture baseplates. The GR-14 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. Preformed teeth are fixed into the denture base by extra gluing process with appropriate glue material.
Performance Testing:
Performance testing for the GR-14 Resin System was performed in accordance with ISO 20795-1 and ISO 22112, including Flexural Strength, Flexural modulus / Bending module, Bond Strength, Color Stability, Water Sorption and Solubility, Fracture toughness, and Total Work of Fracture Testing.
Biocompatibility:
Biocompatibility testing was conducted in accordance with ISO 10993-1.
Shelf-Life:
The shelf life of the GR-14 Resin System is 2 year. Testing was performed in accordance with ASTM F1980-16.
| | Subject Device:
GR-14. Resin System | Predicate Device:
NextDent Denture 3D+ | Predicate Device:
Dentca Denture Base II |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Pro3dure Medical GmbH | Vertex-Dental BV | DENTCA, Inc. |
| 510(k) Number | K210298 | K191497 | K162044 |
| Indications for use | The GR-14.1 denture is a
light-curable polymerizable
resin intended to be used in
conjunction with extraoral
curing light equipment. The
GR-14.1 denture is indicated
for the fabrication and repair,
by additive manufacturing, of
full and partial removable
dentures and baseplates.
The GR-14.2 denture HI is a
light-curable polymerizable
resin intended to be used in
conjunction with extraoral
curing light equipment. The
GR-14.2 denture HI is | NextDent Denture 3D+
is a light-cured resin
indicated for the
fabrication of denture
bases fabricated in
dental laboratories,
including full and
partial removable
dentures. The material
is an alternative to
traditional heat cured
and auto
polymerization.
NextDent Denture 3D+
is intended exclusively
for professional dental
work. Fabrication of | DENTCA Denture
Base II is a light-
curable resin indicated
for the fabrication and
repair of full and partial
removable dentures and
baseplates. The
material is an
alternative to traditional
heat cured and auto
polymerization.
Fabrication of dental
prosthetics with Dentca
Denture Base II
requires a computer-
aided design and
manufacturing (CAD/ |
Comparison to Predicate:
5
| | Subject Device:
GR-14. Resin System | Predicate Device:
NextDent Denture 3D+ | Predicate Device:
Dentca Denture Base II |
|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Pro3dure Medical GmbH
indicated for the fabrication
and repair, by additive
manufacturing, of full and
partial removable dentures and
baseplates. | Vertex-Dental BV
denture bases with
NextDent Denture 3D+
requires a computer-
aided and
manufacturing
(CAD/CAM) system
that includes selected
scanner, design
software, additive
printer and post-cure
unit. | DENTCA, Inc.
CAM) system that
includes the following
components: digital
denture base files based
on a digital impression,
stereolithographic
additive printer, and
curing light equipment |
| | Comparison: The GR-14 Resin System has the same indications as the predicate devices. | | |
| Chemical
Description | Multifunctional
methacrylates/dimethacrylates,
inhibitors, stabilizers,
colors/pigments | Dimethacrylate-based
resin with photo-
initiator and pigments | Polymerizable
monomers |
| Comparison: The GR-14 Resin System has similar chemical characterization as the predicate devices. | | | |
| Curing Method | UV Light | UV Light | UV Light |
| | Comparison: The GR-14 Resin System uses the same curing method as the predicate devices. | | |
| Product State | Liquid | Liquid | Liquid |
| Comparison: The GR-14 Resin System and the predicate devices are provided in liquid form. | | | |
| Manufacturing | Additive | Additive | Additive |
| Comparison: The GR-14 Resin System and the predicate devices use additive manufacturing to
fabricate the final product. | | | |
| Performance
Standards | ISO 20795-1
ISO 22112 | ISO 20795-1 | ISO 20795-1 |
| Comparison: The GR-14 Resin System and the predicate devices comply with the same standards. | | | |
| Biocompatibility | ISO 7405
ISO 10993 | ISO 10993 | ISO 10993 |
| Comparison: The GR-14 Resin System and the predicate devices use biocompatible according to
the same standards. | | | |
Conclusion:
The GR-14 Resin System is substantially equivalent in indications, technical characteristics, function, material. Performance, biocompatibility, and shelf life to the predicate devices.