G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.

Device Description

G-BLOCK is a compact block made of graphene-doped polymer suitable for the manufacture of dental prostheses using CAD/CAM technology. The polymer is based on polymethyl methacrylate (PMMA) doped with graphene (an allotrope of carbon).

G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.

G-BLOCK, compounded of polymethyl methacrylate (PMMA) doped with Graphene, is manufactured using the heat-curing method.

G-BLOCK 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-BLOCK presents high deformation resistance and stress limit, thus avoiding the formation of cracks and fractures.

G-BLOCK is low density making the prosthesis lightweight.

G-BLOCK increases the material hardness comparing with acrylic resins used in dentistry.

G-BLOCK has colour stability.

G-BLOCK has wide chromatic range, even within the same piece, making it look extremely natural.

G-BLOCK is chemically inert.

G-BLOCK 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-BLOCK offers a durable and safety treatment.

G-BLOCK is available in different formats, sizes and colors, having all variations the same physicochemical characteristics.

The device is presented in the form of a polymer block glued to an aluminum pin that allows the device to be fixed on the milling machine so that the block can be milled to obtain dental prostheses with the use of specific CAD/CAM equipment.

G-BLOCK is available in 2 different formats: MONOCHROMA and MULTICHROMA. Monochrome and Multichroma blocks may be both used for anatomical monolithic restorations.

When machined, Monochroma and Multichroma present a different visual effect:

Monochroma, is made of a pure colour matching the dentin.
Multichroma, has a chromatic spectrum based on the natural colour imitating the optical effects of the natural dentition.

Both variants are presented in two sizes: 14 and 40.

G-BLOCK device is available in the following colours, A1, A2, A3, A3.5, B1, B2, BL1, BL2, C2 (according to G-CAM shade guide).

G-BLOCK are provided non-sterile and as a single use device.

G-BLOCK must be used only by professionals as dental lab technicians and / or dentist.

G-BLOCK 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-BLOCK is made is stable and can be stored for an extended period of 5-year shelf life.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - G-Block

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.01

September 29, 2025

Graphenano Dental S.L.
℅ Dave Yungvirt
CEO
Third Party Review Group, LLC
7 Giralda Farms, Suite 120A
Madison, New Jersey 07940

Re: K253236
Trade/Device Name: G-Block
Regulation Number: 21 CFR 872.3690
Regulation Name: Tooth shade resin material
Regulatory Class: Class II
Product Code: EBF, EBG
Dated: September 26, 2025
Received: September 29, 2025

Dear Dave Yungvirt:

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.

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K253236 - Dave Yungvirt
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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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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

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K253236 - Dave Yungvirt
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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 -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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K253236

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K253236

Device Name
G-BLOCK

Indications for Use (Describe)
G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.

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."

FORM FDA 3881 (8/23)
Page 1 of 1

Page 5

G-BLOCK 510(k) Premarket Notification Submission

510(k) SUMMARY

I. SUBMITTER (21 CFR 807.92(a)(1))

DATE PREPARED: 28 September 2025
SUBMITTER NAME: Graphenano Dental S.L.
SUBMITTER ADDRESS: Polígono Industrial Táctica. Calle 2A, n.º 1. 46980 Paterna, Valencia (SPAIN)
CONTACT PERSON: Eva María Navarro Sáez, QA/RA Manager
TELEPHONE: +34 965 108 102
e-mail: Evanavarro@graphenanodental.com

II. DEVICE (21 CFR 807.92(a)(2))

DEVICE TRADE NAME: G-BLOCK
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

III. PREDICATE DEVICE (21 CFR 807.92(a)(3))

Primary Predicate: K220329 G-CAM
Reference Predicate: K160425 CAD/CAMouflage Milling Block

IV. DEVICE DESCRIPTION (21 CFR 807.92(a)(4))

G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.

The previous indications for G-BLOCK are supported by the following concepts:

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G-BLOCK 510(k) Premarket Notification Submission

510(k) SUMMARY

I. SUBMITTER (21 CFR 807.92(a)(1))

II. DEVICE (21 CFR 807.92(a)(2))

III. PREDICATE DEVICE (21 CFR 807.92(a)(3))

Primary Predicate: K220329 G-CAM
Reference Predicate: K160425 CAD/CAMouflage Milling Block

IV. DEVICE DESCRIPTION (21 CFR 807.92(a)(4))

G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.

The previous indications for G-BLOCK are supported by the following concepts:

❖ G-BLOCK, compounded of polymethyl methacrylate (PMMA) doped with Graphene, is manufactured using the heat-curing method.

❖ G-BLOCK 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-BLOCK presents high deformation resistance and stress limit, thus avoiding the formation of cracks and fractures.

❖ G-BLOCK is low density making the prosthesis lightweight.

❖ G-BLOCK increases the material hardness comparing with acrylic resins used in dentistry.

❖ G-BLOCK has colour stability.

❖ G-BLOCK has wide chromatic range, even within the same piece, making it look extremely natural.

❖ G-BLOCK is chemically inert.

❖ G-BLOCK 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-BLOCK offers a durable and safety treatment.

G-BLOCK is available in different formats, sizes and colors, having all variations the same physicochemical characteristics.

DEVICE DESIGN DESCRIPTION

G-BLOCK is available in 2 different formats: MONOCHROMA and MULTICHROMA. Monochrome and Multichroma blocks may be both used for anatomical monolithic restorations.

When machined, Monochroma and Multichroma present a different visual effect:

Monochroma, is made of a pure colour matching the dentin.

Page 7

G-BLOCK 510(k) Premarket Notification Submission

510(k) SUMMARY

Multichroma, has a chromatic spectrum based on the natural colour imitating the optical effects of the natural dentition.

Both variants are presented in two sizes: 14 and 40.

G-BLOCK device is available in the following colours, A1, A2, A3, A3.5, B1, B2, BL1, BL2, C2 (according to G-CAM shade guide).

G-BLOCK are provided non-sterile and as a single use device.

G-BLOCK must be used only by professionals as dental lab technicians and / or dentist.

Page 8

G-BLOCK 510(k) Premarket Notification Submission

510(k) SUMMARY

V. INTENDED USE / INDICATIONS FOR USE (21 CFR 807.92(a)(5))

As established in the Indications for Use Statement:

"G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers."

G-BLOCK is classified under two of the three product codes included in the primary predicate device, G-CAM. Those codes are the following: EBF – Material, Tooth Shade, Resin; EBG – Crown and Bridge Temporary Resin. The intended use of G-BLOCK is reduced compared to G-CAM due to the different shape and dimensions, but both are equivalent. Specifically, one indication of G-BLOCK is that it 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.

The reference device, CAD/CAMouflage Milling Block has the same physical presentation as G-BLOCK as is presented as well by a block shape. The block has smaller dimensions than the disc (primary predicate device shape). 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 as the device proposed.

The differences with G-BLOCK 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))

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-BLOCK with

Page 9

G-BLOCK 510(k) Premarket Notification Submission

510(k) SUMMARY

the Primary Device, G-CAM, 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-BLOCK and the cited predicate and reference devices.

SUMMARY OF SUBSTANTIAL EQUIVALENCE DISCUSSION:

The G-BLOCK technological characteristics are the same as the predicate device G-CAM. Both are thermoplastic materials, designed to be processed with a CAD/CAM system. The main difference is that they are available in different shapes and, therefore, the anchorage to the milling machine is different as well. The primary predicate has a disc shape, and the proposed G-BLOCK has a block shape but is composed of exactly the same 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-BLOCK doesn't raise new issues related to safety and effectiveness. Based on the information provided in this submission, G-BLOCK is substantially equivalent to the primary predicate and reference devices.

The differences in physical properties and chemical compositions between G-BLOCK and the predicate devices do not impact safety and effectiveness. The finished product presented is biocompatible regardless of the shape 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 predicate and reference devices will not pose new concern.

Page 10

G-BLOCK 510(k) Premarket Notification Submission

510(k) SUMMARY

Table.1 Comparison with predicate and reference Device

Feature	Proposed Device: G-BLOCK	Primary Predicate: G-CAM	Reference Device: CAD/CAMouflage Milling Block	Similarities & Differences (when difference with the predicate an explanation will be given)
Manufacturer	Graphenano Dental, S.L.	Graphenano Dental, S.L.	Prismatik Dentalcraft, Inc.	Same as Primary Predicate
510(k) Nº	-	K220329	K160425	-
Class	Class II	Class II	Class II	Same
Device description	Polymer dental block	Polymer dental disc	Composite Restorative Material	Same as Primary Predicate Equivalent to Reference Device
Product code Regulation description	EBF – Material, Tooth Shade Resin EBG – Crown and Bridge Temporary Resin	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	Same as Reference Device Equivalent to Primary Predicate EBI not included for G-BLOCK as larger structures could be milled on a disc (i.e. dentures) not on a block.
Classification	21 CFR 872.3690 21 CFR 872.3770	21 CFR 872.3690 21 CFR 872.3770 21 CFR 872.3760	21 CFR 872.3690 21 CFR 872.3770	Same as Reference Device Equivalent to Primary Predicate

Page 11

G-BLOCK 510(k) Premarket Notification Submission

510(k) SUMMARY

Feature	Proposed Device: G-BLOCK	Primary Predicate: G-CAM	Reference Device: CAD/CAMouflage Milling Block	Similarities & Differences
Indications for Use	G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers	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.	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.	Partially same G-Blocks have shorter indications for use than the primary predicate device which means that all the indications for use from the proposed device are indications for the primary predicate.
Technical characteristics
Flexural Modulus ISO20795 >2000MPa	3200 MPa +/-7% (ISO 20795)	3200 MPa +/-7% (ISO 20795)	-	Same as Primary predicate and equivalent to reference device
Flexural strength ISO20795 >65MPa ISO10477 ≥ 50MPa	140 MPa +/-7% (ISO 20795) 148 MPa (ISO 10477)	140 MPa +/-7% (ISO 20795) 148 MPa (ISO 10477)	> 100 MPa (ISO 10477)	-
Surface hardness	88 ShoreD (ISO 48-4)	88 ShoreD (ISO 48-4)	19,5 KHN (ASTM E384)	-
Water absorption ISO20975 <32 µg/mm³ ISO10477 ≤40 µg/mm³	4 µg/mm³ (ISO 20795)	4 µg/mm³ (ISO 20795)	Water absorption < 40 μg/mm3 (ISO 10477)	-
Residual monomer ISO20795 <2,2%	<0.004% (ISO 20795)	<0.004% (ISO 20795)	-	-
Water solubility	<0.5 µg/mm³	<0.5 µg/mm³	< 7.5 μg/mm3	-

Page 12

G-BLOCK 510(k) Premarket Notification Submission

510(k) SUMMARY

Feature	Proposed Device: G-BLOCK	Primary Predicate: G-CAM	Reference Device: CAD/CAMouflage Milling Block	Similarities & Differences
	ISO20975 <1,6 µg/mm³ ISO10477 ≤7.5 µg/mm³	(ISO 20795)	(ISO 20795)	(ISO 10477)
Compressive strength (MPa)	156 MPa (ISO 5833)	156 MPa (ISO 5833)	-	-
Filler particle size distribution (µ)	21,5 µ (ISO 13320)	21,5 µ (ISO 13320)	-	-
Radio-opacity (mm Al)	Non-radiopaque	Non-radiopaque	-	-
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	Same
Wearing time	Permanent and temporary	Permanent and temporary	Permanent and temporary	Same
Usage	Single patient	Single patient	Single patient	Same
Patient population	Suitable for everyone	Suitable for everyone	Suitable for everyone	Same
Prescription/OTC	Prescription Use Only	Prescription Use Only	Prescription Use Only	Same
Intended as an intraoral device	Yes	Yes	Yes	Same
Device components	No components	No components	No components	Same
Fixed/removable	Fixed / Removable	Fixed / Removable	Fixed / Removable	Same
Design	Block	Disc	Block	Same as Reference Device Different to Primary Predicate
Size	Size14: 12 x 14 x 18mm Size40: 15.5 x 19 x 39 mm	Diameter 98mm Diameter 95mm	Size14: 12 x 14 x 18mm	Same as Reference Device Different to Primary Predicate
Appliance design	CAD/CAM milling	CAD/CAM milling	CAD/CAM milling	Same
Supplied Sterile / Nonsterile	Non- sterile	Non- sterile	Non- sterile	Same
Material	Polymethylmethacrylate PMMA (Polymethylmethacrylate) resin doped with graphene	Polymethylmethacrylate PMMA (Polymethylmethacrylate) resin doped with graphene	Ceramic-filled nanohybrid Polymer resin	Same as Primary predicate and equivalent to reference device

Page 13

G-BLOCK 510(k) Premarket Notification Submission

510(k) SUMMARY

Feature	Proposed Device: G-BLOCK	Primary Predicate: G-CAM	Reference Device: CAD/CAMouflage Milling Block	Similarities & Differences
Raw material:	Monomer Resin Graphene GNF-LS	Monomer Resin Graphene GNF-LS	Polymer resin with fillers and Pigments	Same as Primary predicate and equivalent to reference device
Manufacturing	Powder + Liquid methacrylate-based resins with graphene powder mixed and heat cured	Powder + Liquid methacrylate-based resins with graphene powder mixed and heat cured	Powder + Liquid methacrylate-based resins with fillers and pigments mixed and heat cured	Equivalent to Reference device as new steps are added to mill the block shape and to add the anchorage pin to the block. Same to Primary predicate
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	5 years	Not specified	Same The G-BLOCK shelf life is based on G-CAM shelf life calculation as each block is made by the same raw materials and method as G-CAM and, as well, the storage conditions are the same and the packaging equivalent, only changing in design.

Page 14

G-BLOCK 510(k) Premarket Notification Submission

510(k) SUMMARY

IDENTIFICATION OF THE RISK ANALYSIS METHOD

G-BLOCK 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-BLOCK 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-BLOCK was designed according to applicable standard to its intended use. In addition, each production is subjected to 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 given to the professional clients in documents like Instructions for Use, Work process, Design Parameters Sheet and Labelling. Moreover, G-BLOCK 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, the material that is milled was tested against biocompatibility standards as specified by ISO 7405:2008, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry. Moreover, G-BLOCK 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.

Page 15

G-BLOCK 510(k) Premarket Notification Submission

510(k) SUMMARY

VII. NON-CLINICAL PERFORMANCE DATA

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 design is like designs previously cleared under a premarket notification.

RELIANCE OF STANDARDS

The G-BLOCK 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 material composition per ISO 7405 where the use of ISO 10993 is specified. Results for Cytotoxicity, Sensitization, Irritation, 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-BLOCK product is sufficient for its intended use and is substantially equivalent to the legally marketed predicate device.

Page 16

G-BLOCK 510(k) Premarket Notification Submission

510(k) SUMMARY

SUMMARY DISCUSSION OF CLINICAL DATA

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-BLOCK is substantially equivalent in safety and effectiveness to the cleared primary predicate device and to the reference device based on the results of the physical properties and biocompatibility testing.

Regulation Number and Section

§ 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.