(154 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a dental cement, with no mention of AI/ML or data processing.
No
The device is a dental cement used for definitive cementation of restorations and posts, which falls under restorative dental procedures, not therapeutic treatment of diseases or conditions.
No
Explanation: The device is a resin luting cement used for definitive cementation of dental restorations and endocanal posts. Its purpose is to connect materials, not to diagnose conditions.
No
The device description clearly states it is a "dual-curing, self-adhesive resin luting cement" with physical components (Paste A and B) and a syringe, indicating it is a physical material, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the device as a material for definitively cementing dental restorations and posts to teeth or implants. This is a direct application within the patient's body (in vivo), not a test performed on samples taken from the body (in vitro).
- Device Description: The description reinforces that it's a resin luting cement designed to connect materials to teeth or implants.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on biological specimens. The performance studies focus on the physical and chemical properties of the cement and its biocompatibility, which are relevant for a material used in vivo.
Therefore, OverCEM is a dental material used for restorative procedures, not an IVD.
N/A
Intended Use / Indications for Use
- 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).
- 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
Product codes (comma separated list FDA assigned to the subject device)
EMA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patients' teeth or implants
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Working time
- Setting time
- Flexural strength
- Water sorption
- Solubility
- Color stability
- Radio-Opacity
- . Adhesive bond strength
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.
Clinical Performance Testing:
No clinical testing has been performed on this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength [MPa]: 102.25
Film Thickness [µm]: 23.10
Setting Time [s]: 240 declared in the IFU (200.40 test result)
Working Time [s]: 90
Water sorption [µm/mm³]: .45
Water solubility [µm/mm³]: 0.883
Color stability: Excellent overall behaviour in colour stability tests
Regarding the adhesion strength, the following results are obtained for different substrates:
• Dentin [MPa]: 12.95 ± 2.22
• Enamel [MPa]: 29.62 ± 7.75
• Zirconia ceramic [MPa]: 44.21 ± 6.53
• Glass Ceramic [MPa]: 31.40 ± 5.68
• Composite [MPa]: 31.27 ± 3.51
• Metal [MPa]: 34.84 ± 4.97
The OverCEM devices are radio-opaque.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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
2
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
3
Indications for Use
Submission Number (if known)
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
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.
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.
5
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
-
- 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).
-
- Definitive cementation of endocanal posts.
- Definitive cementation of ceramic, zirconia, composite or metal restorations on implant abutments and က natural teeth.
-
- 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).