(419 days)
No
The summary describes a light-curable resin for additive manufacturing of dental objects. There is no mention of AI or ML in the intended use, device description, or performance studies. The use of "image projection systems" refers to the manufacturing process, not image analysis using AI/ML.
No.
The device is a resin used to fabricate dental objects (e.g., splints, mouthguards), which are therapeutic devices, but the resin itself is a material for manufacturing, not a therapeutic device.
No
The device is a light-curable resin used for the fabrication of orthodontic and dental objects, not for diagnosing medical conditions.
No
The device description clearly states it is a light-curable polymerizable resin, which is a physical material, not software. While it is used in conjunction with additive manufacturing and CAM systems (which involve software), the device itself is the resin.
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 resins are for the "fabrication, by additive manufacturing, of orthodontic and dental objects such as splints, mouthguards, repositioners and retainers." This describes the creation of physical dental appliances.
- Device Description: The description focuses on the composition and properties of the resin material used to build these dental objects.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with biological specimens for diagnostic purposes.
The device is a material used in a manufacturing process to create dental devices, not a diagnostic tool.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MQC, KMY
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
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
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.
1
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 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 |
| Regulatory Affairs | |
| Specialist | |
| Kontoudis Regulatory Consulting, | |
| LLC 804 Umbra Street | |
| Baltimore, MD 21224 | |
| Phone: (443)722-0126 | |
| Email: 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-curable |
| polymerizable resin intended to be used in conjunction with | |
| extra-oral 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, 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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6
| Device | Subject Device: | Primary
Predicate
Device:
GR Splint Resin
System (K211415) | Additional
Predicate
Device:
KeyPrint
KeySplint
Hard
(K203000) | Additional
Predicate Device:
KeyPrint KeySplint
Soft
(K183598) |
|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Pro3dure
Medical
GmbH | Pro3dure Medical
GmbH | Mycone Dental
Supply Co. Inc. | Mycone Dental
Supply Co. Inc. |
| Indications for use | The printodent®
GR-10 guide 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
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,
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 | 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 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. |
| Comparison: The subject and the predicate devices have the same indications. | | | | |
| Chemical Description | Methacrylate
Monomers, photo
initiator | Contains acrylate
monomers and
oligomers, photo
initiator | Contains acrylate
monomers and
oligomers, photo
initiator | Contains acrylate
monomers and
oligomers, photo
initiator |
| 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.