Definitive cementation of inlays, onlays, crowns and bridges, in ceramic or zirconia, composite or metal; 2-3 unit Maryland bridges and 3-unit inlay/onlay bridges (to be avoided for patients with bruxism or periodontitis).
Definitive cementation of endocanal posts.
Definitive cementation of ceramic, zirconia, composite or metal restorations on implant abutments and natural teeth.
Definitive cementation of zirconium oxide superstructures for two-unit abutments

Device Description

OverCEM is dual-curing, self-adhesive resin luting cement. The components consists of Paste A and B, which are filled in a one-body syringe. Both pastes are automixed with a mixing tip. The operating principle of the device is based on two reactions, one self-curing. OverCEM is designed to strongly and stably connect reconstruction materials and endocanal posts to patients' teeth or implants.

AI/ML Overview

The provided text describes the 510(k) summary for the OverCEM SA dental cement devices. While it details performance bench tests conducted, it does not explicitly state specific acceptance criteria for each test or a direct "study" proving the device meets all acceptance criteria in the format of a clinical study report with individual acceptance criteria for each test and its outcome. Instead, it presents a comparison table showing the reported performance of the applicant device (OverCEM) against the predicate device (G-CEM ONE).

However, I can extract the reported device performance from Section 7 ("Performance Bench Tests") and Section 12 ("Comparison of Technology") for the applicant device and infer that these values are presumed to meet internal or regulatory acceptance criteria, as the device received a 510(k) clearance.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, specific acceptance criteria for each test (e.g., "flexural strength must be X MPa or greater") are not explicitly stated in the document. However, the reported performance values for the OverCEM device are provided, and they are implicitly deemed acceptable for 510(k) clearance by the FDA based on substantial equivalence to the predicate.

Performance Test	Reported OverCEM Device Performance (Applicant)	Predicate Device Performance (G-CEM ONE)	Notes
Diametral tensile strength	Not explicitly listed, but implied as part of "Performance Bench Tests"	Not explicitly listed
Film thickness	23.10 µm	5 µm	The applicant device has a higher film thickness than the predicate. This difference was presumably deemed acceptable by the FDA for substantial equivalence.
Compression strength	Not explicitly listed, but implied as part of "Performance Bench Tests"	Not explicitly listed
Working time	90 seconds (at 23°C/73.4°F) / 01:30 (at 35°C/95°F)	165 seconds	The applicant device has a shorter working time at 23°C compared to the predicate, and even shorter at 35°C.
Setting time	240 seconds (declared in IFU, 200.40 test result) (at 23°C/73.4°F) / 04:00 (at 35°C/95°F)	240 seconds	The applicant device's declared setting time is the same as the predicate's, with test results indicating slightly faster setting.
Flexural strength	102.25 MPa	150 MPa	The applicant device has a lower flexural strength than the predicate. This difference was presumably deemed acceptable by the FDA for substantial equivalence, possibly due to other compensating factors or falling within an acceptable range for the intended use.
Water sorption	0.45 µm/mm³	0.0000025 µm/mm³	The units for water sorption differ significantly between the applicant and predicate, making direct comparison difficult without clarification of units or magnitude. The applicant's value is much larger.
Solubility	0.883 µm/mm³	0.0000016 µm/mm³	Similar to water sorption, units or magnitude differences make direct comparison challenging. The applicant's value is much larger.
Color stability	Excellent overall behaviour in colour stability tests	Excellent colour stability	Both devices report excellent color stability.
Radio-Opacity	The OverCEM devices are radio-opaque.	No information on the radio-opacity of the device (for predicate)	The applicant device features radio-opacity, a characteristic for which information on the predicate is not provided in this document.
Adhesive bond strength (Dentin)	12.95 ± 2.22 MPa	9.24 ± 2.06 MPa	The applicant device shows higher adhesive bond strength to dentin.
Adhesive bond strength (Enamel)	29.62 ± 7.75 MPa	26.45 ± 7.72 MPa	The applicant device shows higher adhesive bond strength to enamel.
Adhesive bond strength (Zirconia)	44.21 ± 6.53 MPa	32.45 ± 3.09 MPa	The applicant device shows significantly higher adhesive bond strength to zirconia.
Adhesive bond strength (Glass Ceramic)	31.40 ± 5.68 MPa	19.55 ± 5.06 MPa	The applicant device shows significantly higher adhesive bond strength to glass ceramic.
Adhesive bond strength (Composite)	31.27 ± 3.51 MPa	22.85 ± 4.77 MPa	The applicant device shows higher adhesive bond strength to composite.
Adhesive bond strength (Metal)	34.84 ± 4.97 MPa	29.34 ± 4.71 MPa	The applicant device shows higher adhesive bond strength to metal.
Biocompatibility	Acceptable based on ISO 10993-1, 10993-5, 10993-10 tests	Not explicitly detailed, but implied as legally marketed	In vitro cytotoxicity, skin sensitization, and intracutaneous reactivity tests were performed and found acceptable for OverCEM.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for each individual test. The document mentions "The device has been tested according to ISO 4049:2009... ISO 13116:2015... ISO 7491:2000... and ISO 29022:2013." These ISO standards typically specify minimum sample sizes for their respective tests, but the document does not report the specific number of samples used in these tests for OverCEM.
Data Provenance: The document states, "Data for adhesion strength were obtained from a test performed by Overfibers S.r.l according to ISO 29022:2013." This indicates that at least the adhesion strength data is prospective and conducted by the manufacturer (Overfibers S.r.l.) based in Italy for the applicant device. The provenance for other bench tests is not explicitly stated beyond "The device has been tested according to..."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes physical and chemical performance bench tests of a dental cement, not a diagnostic device or software requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes physical and chemical performance bench tests, not a diagnostic device or software requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing has been performed on this device."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a dental cement, not a software algorithm. The performance tests are for the physical and chemical properties of the material itself.

7. The Type of Ground Truth Used

For the physical and chemical property tests, the "ground truth" is established by adherence to international standards (e.g., ISO standards) for dental materials testing. The outcomes of these standardized tests (e.g., MPa for flexural strength, µm for film thickness) are the "ground truth" for the device's performance attributes. For biocompatibility, the ground truth is compliance with ISO 10993 series for biological evaluation of medical devices.

8. The Sample Size for the Training Set

Not applicable. This device is a dental cement, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device is a dental cement, not an AI/ML algorithm that requires a training set and established ground truth.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 10, 2025

Overfibers S.r.l. Castrenze Genovese Company Representative Via Malatesta.7 Imola (BO), 40026 ITALY

Re: K242366

Trade/Device Name: OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: August 9, 2024 Received: December 11, 2024

Dear Castrenze Genovese:

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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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-device-advicecomprehensive-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-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-comprehensive-regulatory

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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,

MICHAELE. ADJODHA -S

Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K242366

Device Name OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment Indications for Use (Describe) 1. Definitive cementation of inlays, onlays, crowns and bridges, in ceramic or zirconia, composite or metal: 2-3 unit Maryland bridges and 3-unit inlav/onlay bridges (to be avoided for patients with bruxism or periodontitis). 2. Definitive cementation of endocanal posts. 3. Definitive cementation of ceramic, zirconia, composite or metal restorations on implant abutments

and natural teeth.

Definitive cementation of zirconium oxide superstructures for two-unit abutments

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image is a logo for Overfibers. The word "over" is in black, and the word "fibers" is in black with a blue swoosh above it. Below the word "fibers" is the phrase "improve your performance" in red.

510(k) Summary - K242366

1. Contact Details:

Applicant Name :	Overfibers S.r.l.
Applicant Address:	Via Malatesta, 7 Imola (BO) 40026, Italy
Applicant Contact Telephone:	+39 345 5002938
Applicant Contact:	Castrenze Genovese
Applicant Contact Email:	ezio.genovese@overfibers.com
Date Prepared:	11/12/2024
2. Device Name:
Device Trade Name:	OverCEM SA Universal;OverCEM SA Translucent;OverCEM SA Opaque;OverCEM Ti-Abutment;OverCEM Cer-Abutment.
Common Name:	Dental cement
Classification Name:	Cement, Dental
Regulation Number:	872.3275
Product Code(s):	EMA

3. Legally Marketed Predicate Devices

Product	Applicant	510(k) No.	Code No	Predicate	Decision Date
G-CEM ONE	GC America Inc.	K200798	EMA	Primary	11/24/2020

4. Device Description Summary

Image /page/4/Picture/8 description: The image shows three syringes of OverCEM SA Dual-Curing Self-Adhesive Resin Cement. The top syringe is labeled "Opaque", the middle syringe is labeled "Translucent", and the bottom syringe is labeled "Universal". Two blue caps with applicators are shown next to the top syringe.

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Image /page/5/Picture/0 description: The image is a logo for Overfibers. The logo has the word "overfibers" in bold, black letters. There is a blue swoosh above the word "improve your performance" which is in smaller, red letters. The logo is simple and modern.

5. Intended Use/Indications for Use

1. Definitive cementation of inlays, onlays, crowns and bridges, in ceramic or ziroonia, composite or metal; 2-3 unit Maryland bridges and 3-unit inlay/onlay bridges (to be avoided for patients with bruxism or periodontitis).
1. Definitive cementation of endocanal posts.
Definitive cementation of ceramic, zirconia, composite or metal restorations on implant abutments and က natural teeth.
1. Definitive cementation of zirconium oxide superstructures for two-unit abutments

6. Package:

1. Refill OverCEM SA

OverCEM SA syringe (Universal/Translucent/Opaque) 9,5 g (1), T-Mixer regular (8), T-Mixer wide (5) and endo-tip (5).

2. Refill OverCEM Abutment

OverCEM Abutment syringe (Ti-Abutment) 9.5 g (1), T-Mixer reqular (13).

3. Starter Kit OverCEM SA

OverCEM SA syringe (Universal+Translucent+Opaque) 9,5 g (3), T-Mixer regular (24), T-Mixer wide ● (15) and endo-tip (15);
OverCEM SA syringe (Universal) 9,5 g (3), T-Mixer regular (24), T-Mixer wide (15) and endo-tip (15); ●
OverCEM SA syringe (Translucent) 9,5 g (3), T-Mixer regular (24), T-Mixer wide (15) and endo-tip ● (15):
OverCEM SA syringe (Opaque) 9,5 g (3), T-Mixer regular (24), T-Mixer wide (15), and endo-tip (15). ●

4. Starter Kit OverCEM Abutment:

OverCEM Abutment syringe (Ti-Abutment) 9,5 g (3), T-Mixer regular (30); ●
OverCEM Abutment syringe (Cer-Abutment) 9,5 q (3), T-Mixer reqular (30). ●

7. Shelf life and storage condition

Shelf life 2 year: ●
. Recommended for optimal performance, store at temperature of 2-25°C (36.0-77.0°F). Avoid exposure of the cement to direct bright light or humidity during cement application to avoid setting time shortening.

8. Performance Bench Tests

The device has been tested according to ISO 4049:2009 - Dentistry - Polymer-based restorative materials, ISO 13116:2015 - Dentistry - Test Method for Determining Radio-Opacity of Materials, ISO 7491:2000 -Dental materials — Determination of colour stability and ISO 29022:2013 - Dentistry — Notchededge shear bond strength test.

Performance testing includes:

Diametral tensile strength
Film thickness
Compression strength ●

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Image /page/6/Picture/0 description: The image is a logo for Overfibers. The word "over" is in black, and the word "fibers" is in black. There is a blue swoosh above the word "fibers". Below the two words is the phrase "improve your performance".

Working time
Setting time ●
Flexural strength ●
Water sorption
Solubility
Color stability ●
Radio-Opacity ●
. Adhesive bond strength

9. Non-Clinical Performance Testing

A biocompatibility assessment was completed according to ISO 10993-1:2021, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. With reference to the ISO 10993-1 standard, medical devices belonging to the OverCEM family are classified as: externally communicating, tissue/bone/dentin contact devices for a permanent contact duration (>30 days).

The tests performed are:

. In vitro cytotoxicity based on the criteria of the protocol of ISO 10993-5:2009
Skin sensitisation based on the criteria of the protocol of ISO 10993-10:2010 ●
Intracutaneous reactivity based on the criteria of the protocol of ISO 10993-10:2010 ●

In conclusion, biocompatibility of OverCEM is acceptable device from the biological evaluation result.

10. Clinical Performance Testing

No clinical testing has been performed on this device.

11. Comparison of Technology

The applicant and predicate device have the same polymerisation methods.

The raw materials used by the predicate device are substantially equivalent to those of the applicant. The applicant and predicate device are the same in function, and similar in composition and intended use. This supports that the compatibility of the applicant device is substantially equivalent to the predicate devices.

12. Differences

The OverCEM device, unlike the predicate device, is a self-adhesive resin luting cement with dual-curing (selfcuring and light-curing), without the use of a second component (the predicate device needs the combination G-CEM ONE and G-CEM ONE ADHESIVE ENHANCING PRIMER for self-curing).

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Image /page/7/Picture/0 description: The image shows the logo for Overfibers. The word "overfibers" is written in a bold, sans-serif font, with the "over" portion in a lighter color than the "fibers" portion. A blue swoosh underlines the word. Below the word, the phrase "improve your performance" is written in a smaller, sans-serif font.

	Applicant Device (K242366)	Primary predicate (K200798)
Trade name	OverCEM SA Universal	G-CEM ONE
	OverCEM SA Translucent
	OverCEM SA Opaque
	OverCEM Ti-Abutment
	OverCEM Cer-Abutment
Manufacturer	Overfibers S.r.l.	GC Corporation
Prescription/over-the-counter use	Prescription Use	Prescription Use
Product category	Dual-curing, self-adhesive resin luting cement.	Self-adhesive resin cement
Paste/paste ratio	Paste A / Paste B = 1.0 (w/w)	Paste A / Paste B = 1.3 / 1.0 (w/w)
Indication for Use	1. Definitive cementation of inlays, onlays, crowns and bridges, in	1. Cementation of all types of all ceramic, resin and metal-based inlays,
	ceramic or zirconia, composite or metal; 2-3 unit Maryland bridges	onlays, crowns and bridges.
	and 3-unit inlay/onlay bridges (to be avoided for patients with	2. Cementation of metal, ceramic, fiber posts, and cast post and cores.
	bruxism or periodontitis).	3. Cementation of all ceramic and composite veneers.
	2. Definitive cementation of endocanal posts.	4. Final cementation of crowns and bridges on implant abutments.
	3. Definitive cementation of ceramic, zirconia, composite or metal
	restorations on implant abutments and natural teeth.
	4. Definitive cementation of zirconium oxide superstructures for
	two-unit abutments
Product description	The components consists of Paste A and B, which are filled in a	The components consist of Paste A and B, which are filled in a one-body
	one-body syringe. Both pastes are automixed with a mixing tip.	syringe. Both pastes are automixed with a mixing tip and directly applied
	The operating principle of the device is based on two reactions,	to restorations or the prepared cavity.
	one self-curing and one light-curing. OverCEM is designed to
	strongly and stably connect reconstruction materials and
	endocanal posts to patients' teeth or implants.
Instruction for use	1. Tooth preparation;	1. Tooth preparation
	2. Preparation of the root canal;	2. Application of G-CEM ONE ADHESIVE ENHANCING PRIMER
	3. Restoration preparation;	(Optional)
	4. Dispensing;	3. Restoration preparation
	5. Cementation;	4. Dispensing
	6. Excess cement removal;	5. Cementation
	7. Final checks;	6. Excess cement removal
	8. Final polishing.	7. Final set
		8. Final polishing
Curing specification	Light cure using a light curing unit:	Light cure using a light curing unit.
	20-30 sec (>1000mW/cm² lamp)	10 sec. (High Power LED Light) (>1200mW/cm2)
		20 sec. (Halogen/LED) (700 mW/cm2)
	Self-curing:	Self-curing: G-CEM ONE can be combined with the dedicated Adhesive
	35°C/95°F:	Enhancing Primer (AEP). This innovative Primer induces what we call
	Working time: 01:30	"touch cure mechanism” for an accelerated and very effective dark-cure
	Setting time: 04:00	(self-cure) reaction of G-CEM ONE.
	23°C/73.4°F:
	Working time: 03:00
	Setting time: 06:00
Comparison of technology	Methacrylates contained in Paste A polymerize by polymerization	Methacrylates contained in Paste A polymerize by polymerization
	initiators contained in Paste A and Paste B. In addition, they also	initiators contained in Paste A and Paste B. In addition, they also
	polymerize by light irradiation with photo polymerization initiators	polymerize by light irradiation with photo polymerization initiators
	contained in Paste A.	contained in Paste A.
	For self-curing, working and setting times are influenced by	Furthermore, using G-CEM ONE ADHESIVE ENHANCING PRIMER for
	storage temperature, environment and oral temperature. The	the cavity and abutment tooth, surface modification and cement
	curing of OverCEM SA slows down considerably at room	polymerization are promoted and hardened with the cement.
	temperature and accelerates in the oral cavity. OverCEM SA is a	Methacrylates contained in this material are very hydrophobic and set
	dual material and therefore sensitive to daylight and artificial light.	material is stable. Therefore, the ingredients in the cured material are
	The working time is reduced if it is used under a white light	difficult to elute in water.
	operating lamp: reduce the light intensity to avoid unwanted
	polymerisation.	Flexural Strength [MPa]: 150
	Methacrylates contained in this material are very hydrophobic and	Film Thickness [µm]: 5
	set material is stable. Therefore, the ingredients in the cured	Setting Time [s]: 240
	material are difficult to elute in water.	Working Time [s]: 165
		Water sorption [µm/mm³]: 0.0000025
	Flexural Strength [MPa]: 102.25	Water solubility [µm/mm³]: 0.0000016
	Film Thickness [µm]: 23.10	Color stability: Excellent colour stability
	Setting Time [s]: 240 declared in the IFU (200.40 test result)
	Working Time [s]: 90	Regarding the adhesion strength, the following results are obtained for
	Water sorption [µm/mm³]: .45	different substrates:
	Water solubility [µm/mm³]: 0.883	Dentin [MPa]: 9.24 ± 2.06
	Color stability: Excellent overall behaviour in colour stability tests	Enamel [MPa]: 26.45 ± 7.72
		Zirconia ceramic [MPa]: 32.45 ± 3.09
Regarding the adhesion strength, the following results are obtained for different substrates:• Dentin [MPa]: $12.95 \pm 2.22$• Enamel [MPa]: $29.62 \pm 7.75$• Zirconia ceramic [MPa]: $44.21 \pm 6.53$• Glass Ceramic [MPa]: $31.40 \pm 5.68$• Composite [MPa]: $31.27 \pm 3.51$• Metal [MPa]: $34.84 \pm 4.97$	• Glass Ceramic [MPa]: $19.55 \pm 5.06$• Composite [MPa]: $22.85 \pm 4.77$• Metal [MPa]: $29.34 \pm 4.71$There is no information on the radio-opacity of the device.The data on the properties of the device were taken from the documentation that the manufacturer made available on its website and from the scientific literature.Data for adhesion strength were obtained from a test performed by Overfibers S.r.l according to ISO 29022:2013.
The OverCEM devices are radio-opaque.

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Image /page/8/Picture/0 description: The image shows the logo for Overfibers. The word "overfibers" is written in a bold, sans-serif font, with the "over" in a smaller font size than "fibers". A blue swoosh underlines the word "overfibers". Below the logo, the tagline "improve your performance" is written in a smaller, sans-serif font.

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Image /page/9/Picture/0 description: The image is a logo for Overfibers. The word "overfibers" is written in a stylized font, with the "over" in black and the "fibers" in black. A blue swoosh underlines the word. Below the word is the tagline "improve your performance" in a smaller font.

13. Conclusion

Based on similatities in intented use, mode of composition, and performance testing, OverCEM, is substantialy equivated device G-CEM ONE (K200798).

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.