Who is the manufacturer of G-CAM?

Graphenano Dental S.L. filed the 510(k) submission for G-CAM (K220329).

What is the FDA product code for G-CAM?

EBF. It is classified under 21 CFR 872.3690 as a Class 2 device in the Dental panel.

What is the regulatory pathway for G-CAM?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like G-CAM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

G-CAM

K220329 · Graphenano Dental S.L. · EBF · Aug 16, 2022 · Dental

Device Facts

Record ID	K220329
Device Name	G-CAM
Applicant	Graphenano Dental S.L.
Product Code	EBF · Dental
Decision Date	Aug 16, 2022
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 872.3690
Device Class	Class 2

Intended 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.

Device Story

G-CAM is a thermoplastic acrylic disc composed of PMMA resin doped with graphene; used by dental lab technicians or dentists to manufacture dental prostheses via CAD/CAM milling. The device is processed by milling machines to create monolithic restorations; no additional curing steps required. Output is a finished dental prosthesis (denture, crown, bridge, etc.) for intraoral use. Benefits include high modulus, high deformation resistance, low density, and natural appearance. Used in dental clinics/labs; healthcare providers use the output to restore patient dentition. Device is non-sterile, single-use, and available in various thicknesses, colors, and anchor dimensions.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including mechanical performance (flexural modulus, flexural strength, surface hardness, compressive strength) and biocompatibility (cytotoxicity, sensitization, acute systemic toxicity, subchronic toxicity, material-mediated pyrogenicity, genotoxicity, carcinogenicity) per ISO 7405 and ISO 10993.

Technological Characteristics

Thermoplastic disc; PMMA resin doped with graphene. Dimensions: 98.5mm (Universal) or 95mm (Zirkonzahn) diameter; 14-30mm thickness. Processing: CAD/CAM milling. Non-sterile. Biocompatible. Conforms to ISO 20795-1, ISO 10477, ISO 4049, ISO 5833, ISO 48-4, and ASTM E384.

Indications for Use

Indicated for patients requiring full/partial removable dentures, implant overdentures, or permanent/temporary dental restorations (crowns, bridges, inlays, onlays, veneers, copings, substructures). Suitable for all patients.

Regulatory Classification

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.

Predicate Devices

JUVORA Dental Disc (K160918)

Reference Devices

CAD/CAMouflage Milling Block (K160425)

Related Devices

K253236 — G-BLOCK · Graphenano Dental S.L. · Sep 29, 2025
K180578 — Harvest Dental Polymer Blocks · Harvest Dental Products, LLC · Dec 12, 2018
K192153 — Portux CAD/CAM Disc · New Stetic, SA · Nov 7, 2019
K140894 — ARGEN PMMA · The Argen Corporation · Jul 31, 2014
K172764 — Keymill · Mycone Dental Supply Company, Inc. (Aka Keystone Industries) · Apr 27, 2018

Submission Summary (Full Text)

{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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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. K220329 ### 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. {4}------------------------------------------------ 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: {5}------------------------------------------------ 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). {6}------------------------------------------------ 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)) {7}------------------------------------------------ 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. {8}------------------------------------------------ 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 {9}------------------------------------------------ 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 < 40 µg/mm3 (ISO 10477) | | < 7.5 µg/mm3 (ISO 10477) | | | Flexural strength ISO20795 >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 <32 µg/mm³ ISO10477 <40 µg/mm³ | | Water absorption 4 µg/mm³ (ISO 20795) | | | | | | | | | Residual monomer ISO20795 <2,2% | | <0.004% (ISO 20795) | | | | | | | | | Water solubility ISO20975 <1,6 µg/mm³ ISO10477 <7.5 µg/mm³ | | | | <0.5 µg/mm³ (ISO 20795) | | | | | | | Compressive strength (MPa) (ISO 5833) | | | | | | 156 MPa (ISO 5833) | | | G-CAM 0(k) Premarket Notification Submission {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Graphenano Dental. The logo consists of a blue hexagon with a white tooth inside. The text "Graphenano" is written vertically in black, and the word "DENTAL" is written vertically in blue to the right of "Graphenano". ### G-CAM ### ECTION 05 — 510(k) SUMMAR | Filler particle size distribution (μ) | 21,5 μ (ISO 13320) | | | | | |---------------------------------------|--------------------------------------------------------------------------------------|------------------------------------------------------|---------------------------------------------------|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance testing | Conforms with ISO 20795-1 Conforms with ISO 10477 | Conforms with ISO 20795-1 Conforms with ISO 10477 | Conforms with ISO 4049 Conforms with ISO 10477 | | | | Wearing time | Permanent and temporary | Permanent and temporary | Permanent and temporary | | | | Usage | Single patient | Single patient | Single patient | | | | Patient population | Suitable for everyone | Suitable for everyone | Suitable for everyone | | | | Prescription/OTC | Prescription Use Only | Prescription Use Only | Prescription Use Only | | | | Intended as an intraoral device | Yes | Yes | Yes | | | | Device components Fixed/removable | No components Fixed / Removable | No components Fixed/Removable | No components Fixed/Removable | | | | Design | Disc | Disc | Block | Same as Primary Predicate Different to Reference Device | | | Appliance design | CAD/CAM milling | CAD/CAM milling | CAD/CAM milling | | | | Supplied Sterile / Nonsterile | Non- sterile | Non- sterile | Non- sterile | | | | Material | Polymethylmethacrylate PMMA (Polymethylmethacrylate) resin doped with graphene | PEEK-OPTIMA™ LT1 | Ceramic-filled nanohybrid Polymer resin | | Difference/Equivalence Despite the differences in formulat between the subject device and predicate, they can be conside equivalent, as these differences d not affect clinical performance safety. These Materials are commo used in the dental sector and all them achieve the applicable stand requirements. | | Raw material: | Monomer Resin Graphene GNF-LS | PEEK (Polyetheretherketone) | Polymer resin with fillers and Pigments | | Difference/Equivalence Despite the differences in formulat between the subiect device and | SECTION 05 -8/12 {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Graphenano Dental. The logo consists of a blue hexagon with a white tooth inside. The text "Graphenano" is written vertically in black, and the word "DENTAL" is written horizontally in blue. ### G-CAM ## ECTION 05 — 510(k) SUMMARY | | | | | predicate, they can be considered equivalent since these differences does not affect clinical performance and safety. Materials commonly used in the dental sector and all of them pass the requirements of the standards | |------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturing | Powder + Liquid methacrylate-based resins with graphene powder mixed and heat cured | PEEK can be processed by conventional methods used to process other plastics such as injection molding, extrusion, blow molding, and thermoforming | Powder + Liquid methacrylate-based resins with fillers and pigments mixed and heat cured | Different to the primary predicate due to the difference in material Same to Reference device | | Maintenance | Oral hygiene | Oral hygiene | Oral hygiene | Same | | Cleaning | Not specified | Not specified | Not specified | Same | | Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Same | | Shelf life | 5 years | 10 years | Not specified | Difference/Equivalence The G-CAM shelf life is evaluated using the real-time testing method. the first produced discs have less than 10 years we can't ensure with the method that shelf life is arriving to age, even if we believe so. Then provide, the confirmed by the real- time testing, 5 years. The shorter value on shelf life is not substantial due to the already explained reasons. | ### SECTION 05 -9/12 {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for Graphenano Dental. The word "Graphenano" is written in a dark brown, 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. ### IDENTIFICATION OF THE RISK ANALYSIS METHOD G-CAM has conducted a preliminary hazard analysis which identify risks, including risk of mechanical failure, toxicity and adverse tissue reaction, improper use, and incompatibility with other dental devices. The Failure Modes Effect Analysis (FMEA) showed that all risks, when reduced as far as possible, were acceptable. There were no so severe risks found to cause severe damage or that lead to the death of a patient. The device mechanical properties are comparable to predicate devices. The biocompatibility testing showed that G-CAM is biocompatible. The labeling of the device is designed to reduce the risk of improper use. ### DISCUSSION OF THE DEVICE CHARACTERISTICS To reduce the risk of mechanical failure, G-CAM was designed according to applicable standard to its intended use. In addition, each production is subjected to an exhaustive quality control to check that the product is in accordance with its technical specifications. Also, to reduce the risk of mechanical failure cause of milling errors, specific information is qiven to the professional clients in documents like Instructions for Use, Work process, Design Parameters Sheet and Labelling, Moreover, G-CAM is a thermoplastic solid material, so additional curing steps are not needed which prevents improper fabrication due to varying curing or working times. To reduce the risk of toxicity and adverse tissue reaction, G-CAM was tested against biocompatibility standards as specified by ISO 7405:2008, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry. Moreover, G-CAM labeling is designed to reduce the risk of improper use. ### DESCRIPTION OF THE PERFORMANCE ASPECTS (21 CFR 807.92 (b)(1)(2)) 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. ### VII. NON-CLINICAL PERFORMANCE DATA {13}------------------------------------------------ Image /page/13/Picture/0 description: The image contains the logo for Graphenano Dental. The logo features the word "Graphenano" in a dark brown, sans-serif font, with the word "DENTAL" in a smaller, teal font below it. To the right of the text is a teal hexagon with a white tooth icon inside. The logo is clean and modern, suggesting a dental company that utilizes advanced materials or technology. ### SUMMARY DISCUSSION OF NON-CLINICAL DATA: The subject device has been subject to bench to determine conformance to performance specifications and requirements taking account of its intended use and following all recommendations set out in FDA Document "Dental Composite Resin Devices-Premarket Notification [510(k)] Submissions". Non-clinical testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use and specifically included mechanical performance. Clinical testing is not required to demonstrate substantial equivalence as the indications for use are like legally marketed devices and the designs previously cleared under a premarket notification. ### RELIANCE OF STANDARDS 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. ### SUMMARY DISCUSSION OF CLINICAL DATA {14}------------------------------------------------ Image /page/14/Picture/0 description: The image contains the logo for Graphenano Dental. The word "Graphenano" is written in a dark brown sans-serif font, and 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 510(k) Premarket Notification Submission ### SECTION 05 - 510(k) SUMMARY Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence. No clinical studies are submitted. ### VIII. CONCLUSIONS The results of the above-described studies demonstrate that the G-CAM discs are substantially equivalent in safety and effectiveness to the cleared primary predicate device and to the reference device based on the results of the physical property and biocompatibility testing.