(193 days)
No
The summary describes a material (thermoplastic acrylic disc) used in CAD/CAM technology for dental prostheses. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the material properties and mechanical performance.
No
This device is a material (thermoplastic acrylic disc) used to manufacture dental prostheses and restorations, which are considered medical devices, but the disc itself is not directly therapeutic.
No
The device description clearly states that G-CAM discs are "suitable for the creation of dental prostheses" and are "intended to be used for the manufacture of full and partial removable dentures as well as permanent and temporary restorations." This indicates it is a manufacturing material for medical devices, not a device used for diagnosis.
No
The device description clearly states that G-CAM is a thermoplastic acrylic disc made of PMMA resin doped with graphene, which is a physical material used for manufacturing dental prostheses. The performance studies also focus on mechanical and biocompatibility testing of this material.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the G-CAM discs are used for the manufacture of dental prostheses (dentures, crowns, bridges, etc.). This is a manufacturing process for a medical device that will be placed in the body.
- Device Description: The description reinforces that it's a material (thermoplastic acrylic disc) used for creating dental prostheses.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample from the human body, or provide information about a patient's health status. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to detect diseases, conditions, or infections.
- Performance Studies: The performance studies focus on the material's mechanical properties, biocompatibility, and strength, which are relevant to its use as a dental restorative material, not as a diagnostic tool.
The G-CAM disc is a material used in the creation of a medical device (dental prostheses), but it is not a diagnostic device itself.
N/A
Intended Use / Indications for Use
G-CAM discs are intended to be used for the manufacture of full and partial removable dentures as well as permanent and temporary restorations such as anterior or posterior crowns and bridges, inlays, veneers, copings and substructures.
Product codes (comma separated list FDA assigned to the subject device)
EBF, EBF, EBG
Device Description
G-CAM is a thermoplastic acrylic disc made by a principal base of polymethyl methacrylate (PMMA) resin doped with graphene (allotropic form of carbon), suitable for the creation of dental prostheses using CAD/CAM technology.
G-CAM discs are intended to be used for the manufacture of full and partial removable dentures, implant overdentures as well as permanent and temporary restorations such as anterior or posterior crowns and bridges, inlays, onlays, veneers, copings and substructures.
Mentions image processing
Not Found
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
G-CAM must be used only by professionals as dental lab technicians and / or dentist.
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)
The testing of the performance aspects was performed to recognized standards, such as ISO 20795-1 and ISO 10477. (see Table 1 for specific application knowledge). There are no deviations to the procedure of the standard for the tests performed.
Non-clinical testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use and specifically included mechanical performance.
The G-CAM product has demonstrated conformance with the non-clinical performance requirements through evaluation and testing in accordance with the following standards:
- Chemical and physical testing having under considerations ISO 4049; ISO 20795-1 and ISO 10477 (Compression, Elastic modulus, Bending strength, Water absorption and Residual monomer, radiopaque...)
- Biocompatibility check for G-CAM material composition per ISO 7405 where the use of ISO 10993 is specified. Results for Cytotoxicity, Sensitization, Acute Systemic Toxicity, Subchronic Toxicity by Subcutaneous Implantation, Material-Mediated Pyrogenicity, Genotoxicity and Carcinogenicity concluded that the device is biocompatible.
The results of this non-clinical testing show that the strength of the G-CAM product is sufficient for its intended use and is substantially equivalent to the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics mentioned as part of the performance testing are: Flexural Modulus (3200 MPa +/-7%), Flexural Strength (140 MPa +/-7%, 148 MPa), Surface Hardness (88 ShoreD, 19,5 KHN), Water absorption (4 microgram/mm3), Residual monomer (
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the 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 includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
August 16, 2022
Graphenano Dental S.L. Maria Garcia QA/RA Manager C/ Pablo Casals , 13 Ba. Yecla, Murcia 30510 SPAIN
Re: K220329
Trade/Device Name: G-CAM Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBF, EBG Dated: April 8, 2022 Received: June 17, 2022
Dear Maria Garcia:
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K220329
Device Name G-CAM
Indications for Use (Describe)
G-CAM discs are intended to be used for the manufacture of full and partial removable dentures as well as permanent and temporary restorations such as anterior or posterior crowns and bridges, inlays, veneers, copings and substructures.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/0 description: The image contains the logo for Graphenano Dental. The logo consists of the word "Graphenano" in a bold, dark gray font, with the word "DENTAL" underneath in a smaller, light blue font. To the right of the text is a light blue hexagon with a white tooth inside. The logo is clean and modern, with a focus on the company name and a visual representation of the dental industry.
SECTION 05 - 510(k) SUMMARY
I. SUBMITTER (21 CFR 807.92(a)(1))
| DATE OF SUBMISSION: | 2022-04-08 |
|---|---|
| SUBMITTER NAME: | Graphenano Dental S.L. |
| SUBMITTER ADDRESS: | C/ Pablo Casals, 13 bajo. |
| 30510 Yecla, Murcia | |
| SPAIN | |
| CONTACT PERSON: | María Simón García, QA/RA Manager |
| TELEPHONE: | +34 965 108 102 |
| e-mail: | mariasimon@graphenano.com |
II. DEVICE (21 CFR 807.92(a)(2))
| DEVICE TRADE NAME: | G-CAM |
|---|---|
| COMMON NAME: | Tooth Shade Resin Material |
| CLASSIFICATION NAME: | Material, tooth shade, resin |
| REGULATION DESCRIPTION: | Tooth Shade Resin Material |
| CLASS: | Class II (Special Controls) |
| REGULATION NUMBER: | 21 CFR 872.3690 |
| PRODUCT CODE: | EBF - Material, Tooth Shade, Resin |
| SUBSEQUENT PRODUCT CODES: | EBG - Crown and Bridge Temporary Resin |
| EBI - Denture Relining, Repairing, Rebasing Resin |
III.PREDICATE DEVICE (21 CFR 807.92(a)(3))
Primary Predicate: K160918 JUVORA Dental Disc
Reference Predicate: K160425
CAD/CAMouflage Milling Block
IV. DEVICE DESCRIPTION (21 CFR 807.92(a)(4))
G-CAM is a thermoplastic acrylic disc made by a principal base of polymethyl methacrylate (PMMA) resin doped with graphene (allotropic form of carbon), suitable for the creation of dental prostheses using CAD/CAM technology.
G-CAM discs are intended to be used for the manufacture of full and partial removable dentures, implant overdentures as well as permanent and temporary restorations such as anterior or posterior crowns and bridges, inlays, onlays, veneers, copings and substructures.
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Image /page/4/Picture/0 description: The image contains the logo for Graphenano Dental. The logo consists of the word "Graphenano" in a dark gray, sans-serif font, with the word "DENTAL" in a light blue, sans-serif font underneath. To the right of the text is a light blue hexagon with a white tooth icon inside. The logo is clean and modern, and the color scheme is professional and calming.
The previous indications for G-CAM are supported by the following concepts:
- & G-CAM, polymethyl methacrylate (PMMA) doped with Graphene, is manufactured using the heat-curing method.
- & G-CAM presents high modulus and elastic limit to ensure that the tensions generated during biting and chewing do not cause permanent deformations, and it is possible to manufacture prosthesis of smaller sections.
- & G-CAM presents high deformation resistance and stress limit, thus avoiding the formation of cracks and fractures.
-
- G-CAM is low density making the prosthesis lightweight.
- & G-CAM increases the material hardness comparing with acrylic resins used in dentistry.
- & G-CAM final appearance is similar to oral tissue. Thus ideal for visible areas.
- ❖ G-CAM has colour stability.
-
- G-CAM has wide chromatic range, even within the same piece, making it look extremely natural.
-
- G-CAM disc is chemically inert.
- ❖ G-CAM water absorption is 4 µg/mm3 and a solubility of 0.5 µg/mm2. The release of residual monomer is minimum, with a percentage of 0.004% of residual monomer. Thanks to these physical properties G-CAM offers a durable and safety treatment.
G-CAM is available in different formats, thicknesses, colors and anchors, having all the variations the same physicochemical characteristics.
DEVICE DESING DESCRIPTION
The device is presented in a disc form which allow to process the dental prostheses with specific CAD /CAM equipment.
G-CAM disc is available in 2 different formats: G-CAM MONOCHROMA and G-CAM MULTICHROMA. Monochrome and Multichroma discs may be both used for anatomical monolithic restorations.
When machined, G-CAM Monochroma and G-CAM Multichroma present a different visual effect:
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Image /page/5/Picture/0 description: The image shows the logo for Graphenano Dental. The word "Graphenano" is written in a dark gray sans-serif font. Below it, the word "DENTAL" is written in a light blue sans-serif font. To the right of the text is a light blue hexagon with a white tooth inside.
- G-CAM Monochroma, is made of one pure VITA Classic guide's colour. .
- . G-CAM Multichroma, it has a chromatic spectrum based in natural colour imitating the optical effects of the natural pieces.
The more suitable choice between monochrome and multichrome disc will depend on the final application given to the device.
G-CAM is presented as a compacted resin disc offered in two different anchor dimensions.
There are two different discs variants base on the specified type of anchor used by the CAM device:
Universal anchorage: disc of 98.5mm diameter
Zirkonzahn anchorage: disc of 95mm diameter
Both variants are presented in different thicknesses: 14,16, 18, 20, 22, 24, 26, 28 and 30.
G-CAM device is available in the following colours TRANSPARENT, A1, A2, A3, A3.5, B1, B2, BL1, BL2, C2 and PINK (according to VITA classic guide).
G-CAM discs are provided non-sterile and as a single use device.
G-CAM must be used only by professionals as dental lab technicians and / or dentist.
G-CAM should be stored at room temperature in its original packaging, in dry storage and avoid exposure to direct sunlight. PMMA polymer from which the G-CAM disc is made is stable and can be stored for an extended period of time having a calculated 5-year shelf life (real-time testing method).
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Image /page/6/Picture/0 description: The image shows the logo for Graphenano Dental. The word "Graphenano" is written in a bold, dark gray font. Below it, the word "DENTAL" is written in a smaller, light blue font. To the right of the text is a light blue hexagon with a white tooth inside.
V. INTENDED USE / INDICATIONS FOR USE (21 CFR 807.92(a)(5))
As established in the Indications for Use Statement:
"G-CAM discs are intended to be used for the manufacture of full and partial removable dentures, implant overdentures as well as permanent and temporary restorations such as anterior or posterior crowns and bridges, inlays, onlays, veneers, copings and substructures."
The primary predicate device, Juvora dental disc, and G-CAM, are classified under the same product codes: EBF - Material, Tooth Shade, Resin; EBG - Crown and Bridge Temporary Resin; EBI -Denture Relining, Repairing, Rebasing Resin. As can be seen in Table.1, below, the intended use of G-CAM and the Juvora dental disc is equivalent. Specifically, one indication of G-CAM is that is intended for final crowns and bridges, inlays, onlays and veneers restorations which means that can be used as a direct monolithic solution with no need of using other materials to make aesthetics restorations. Juvora dental disc is intended for frameworks used on such restorations being possible the necessity of some other materials to make is more aesthetic.
The reference device, CAD/CAMouflage Milling Block, has a same intended use that one of the G-CAM intended use but more restricted. The CAD/CAMouflage Milling Block physical presentation is different as is presented as a block with smaller width dimensions than the disc. Its usefulness is intended for small parts so that is only classified as EBF- Material, Tooth Shade, Resin and EBG -Crown and Bridge Temporary Resin.
The differences with G-CAM and those two predicate devices do not affect the safety and effectiveness of the device when used as labeled.
VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE PROPOSED DEVICE AND THE PREDICATE DEVICES (21 CFR 807.92(a)(6))
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Image /page/7/Picture/0 description: The image shows the logo for Graphenano Dental. The word "Graphenano" is in a dark gray sans-serif font, with the word "DENTAL" in a smaller, light blue sans-serif font underneath. To the right of the text is a light blue hexagon with a white tooth inside. The logo is clean and modern, and the colors are calming and professional.
Graphenano Dental has used the FDA's Guidance for Industry and FDA Staff – "Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions'' for comparing its G-CAM with the Primary Device, JUVORA Dental Disc, and Reference device, CAD/CAMouflage Milling Block. Both are legally marketed devices under 21 CFR 807.92(a)(3) classified as Class II. The technological characteristics comparison table (Table 1) outline and provides the difference, similarities and the substantial equivalency of G-CAM and the cited predicate and reference devices.
SUMMARY OF SUBSTANTIAL EQUIVALENCE DISCUSSION:
Most of the G-CAM technological characteristics are substantially equivalent to the predicate device JUVORA Dental Disc. Both are thermoplastic materials, available in disc format and designed to be processed with a CAD/CAM system. The main difference is that they are composed of different raw materials. Both devices have been evaluated under the applicable standards for their intended use and they achieve the required values established by those.
When compared to the primary and reference predicate devices, the intended use and technological characteristics of G-CAM doesn't raise new issues related to safety and effectiveness. Based on the information provided in this submission, G-CAM is substantially equivalent to the primary predicate and reference devices.
The differences on physical properties and chemical compositions between G-CAM and the predicate devices do not impact safety and effectiveness. The finished product is biocompatible regardless of the material variation.
In general, we consider the proposed device to be substantially equivalent to the predicate device and consider that any differences between the proposed and reference devices will not pose new concern.
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Image /page/8/Picture/0 description: The image shows the logo for Graphenano Dental. The logo consists of a hexagon with a tooth inside of it. The text "Graphenano" is written vertically in a large, bold font, and the word "DENTAL" is written vertically in a smaller font to the right of "Graphenano."
G-CAM
ECTION 05 – 510(k) SUMMAR
Table.1 Comparison with predicate and reference Device
| Feature | Proposed Device:
G-CAM | Primary Predicate:
JUVORA™ Dental Disc | Reference Device:
CAD/CAMouflage Milling Block | Similarities & Differences (with
difference with the predicate and
explanation will be given) |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Graphenano Dental, S.L. | Juvora, Ltd. | Prismatik Dentalcraft, Inc. | |
| 510(k) N° | K220329 | K160918 | K160425 | |
| Class | Class II | Class II | Class II | Same |
| Device description | Thermoplastic dental disc | Thermoplastic dental disc | Composite Restorative Material | Same Primary Predicate
Equivalent to Reference Device |
| Product code- Regulation
description | EBF – Material, Tooth Shade Resin
EBG – Crown and Bridge Temporary
Resin | EBI – Denture Relining, Repairing,
Rebasing Resin
EBF – Material, Tooth Shade Resin
EBG – Crown and Bridge Temporary
Resin | EBF – Material, Tooth Shade Resin
EBG – Crown and Bridge Temporary
Resin | Same as Primary Predicate
Equivalent to Reference Device |
| | EBI - Denture Relining, Repairing,
Rebasing Resin | | | EBI not included on the reference
device codes as larger structures
could be milled on a disc (i.e.
dentures) than on the size block. |
| Classification | 21 CFR 872.3690
21 CFR 872.3770
21 CFR 872.3760 | 21 CFR 872.3760
21 CFR 872.3690
21 CFR 872.3770 | 21 CFR 872.3690
21 CFR 872.3770 | Same as Primary Predicate
Equivalent to Reference Device |
| Indications for Use | G-CAM discs are intended to be used
for the manufacture of full and partial
removable dentures, implant
overdentures as well as permanent and
temporary restorations such as anterior
or posterior crowns and bridges, inlays,
onlays, veneers, copings and
substructures. | The JUVORA™ Dental Disc is a
thermoplastic dental disc. They are
intended to be used for the
manufacture of:
i) Full and partial removable dentures
and implant overdentures.
ii) Copings, substructures (cemented
or uncemented), frameworks for
permanent and transitional anterior or
posterior crowns and bridgework. | CAD/CAMouflage Milling Block is
indicated as an indirect restorative for
both anterior and posterior restorations,
including occlusal surfaces. The
CAD/CAMouflage Milling Block is
made for fabricating temporary and
permanent restorations such as inlays,
onlays, veneers and full crown
restorations. | Substantially Equivalent
G-CAM therefore could be used as a
direct monolithic solution which
means that it does no need using other
materials to make aesthetic
restorations while the primary
predicate disc would normally need
other material to show a more
aesthetic solution. |
SECTION 05 -6/12
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Image /page/9/Picture/5 description: The image contains the logo for Graphenano Dental. The logo consists of a blue hexagon with a white tooth inside. The text "Graphenano" is written vertically in a dark gray font, and the word "DENTAL" is written vertically in a smaller, light blue font to the right of "Graphenano".
| | | | | Equivalent.
Despite being different materials,
properties are similar and the
standard requirements are achiev | | | | | |
|-------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------------|-----------------------|-----------------------------|--|
| Flexural
Modulus
ISO20795
2000MPa | | | | > 100 MPa
(ISO 10477) | | Water absorption
65MPa
ISO10477
≥ 50MPa | 3200 MPa +/-7%
(ISO 20795) | 3995 MPa
(ISO 20795) | | | | Water absorption
5 µg/mm3
(ISO 20795) | | | |
| Surface
hardness | 140 MPa +/-7%
(ISO 20795)
148 MPa
(ISO 10477) | 165 MPa
(ISO 20795)
192 MPa
(ISO 10477) | | | | | | | |
| | 88 ShoreD
(ISO 48-4)
19,5 KHN
(ASTM E384) | | | | | | | | |
| Technical
characteri
stics | Water
absorption
ISO20975