(89 days)
Unknown
The device name includes "ML", which could indicate Machine Learning, but the description focuses solely on the material composition and physical properties of the ceramic blank. There is no mention of any software, algorithms, or data processing that would typically be associated with AI/ML in a medical device.
No
The device is a ceramic blank used to fabricate dental restorations, which are considered prosthetics or replacements for anatomical structures, not devices that treat or prevent a disease.
No
Explanation: The device is a partially sintered ceramic blank used to fabricate dental restorations like crowns, bridges, inlays, onlays, and veneers. Its intended use is to replace missing or damaged teeth, which is a restorative function, not a diagnostic one.
No
The device description clearly states it is a "partially sintered ceramic blank composed of yttrium oxide-(yttria-) stabilized zirconium oxide (zirconia) (Y-TZP)" and is a physical material used to fabricate dental restorations. This is a hardware device, not software.
Based on the provided information, the device Cercon® yo ML is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for fabricating dental restorations (crowns, bridges, inlays, onlays, veneers) for placement in the anterior and posterior segments of the mouth. This is a therapeutic/restorative use, not a diagnostic one.
- Device Description: The device is a partially sintered ceramic blank that is processed to create dental restorations. This is a material used for physical reconstruction, not for analyzing biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies focus on the physical and biological properties of the material itself (flexural strength, CTE, solubility, biocompatibility), which are relevant for a dental restorative material, not an IVD.
- Predicate and Reference Devices: The listed predicate and reference devices are also dental restorative materials or systems, further supporting that this device falls within the dental restorative category.
In summary, an IVD is a medical device used to perform tests on samples taken from the human body to help diagnose, monitor, or treat diseases or conditions. Cercon® yo ML is a material used to create physical restorations for teeth, which is a different category of medical device.
N/A
Intended Use / Indications for Use
Cercon® yo ML is indicated in the anterior and posterior segments for:
- Crowns
- Multi-unit bridges (with a maximum of two pontics between abutment crowns)
- Inlays, onlays and veneers
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
The proposed Cercon® yo ML is a partially sintered ceramic blank composed of yttrium oxide-(yttria-) stabilized zirconium oxide (zirconia) (Y-TZP). Cercon® yo ML is a multilayer disk built out of different shade layers and yttrium oxide contents which create a natural gradient of the restoration after sintering. The proposed device is supplied to dental professionals as a blank and then processed by machining and subsequent sintering to fabricate dental ceramic restorations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior segments (dental)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals
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 Testing:
The proposed device was tested and conforms to:
- ISO 6872:2015 Amd 1. 2018 Dentistry Ceramic Materials O
- ISO 9693:2019 Dentistry Compatibility testing for metal-ceramic-ceramic-ceramic-ceramic systems
Results from ISO 6872:2015 Amd 1. 2018:
- Flexural Strength: Pass (≥ 800 MPa)
- CTE (Coefficient of Thermal Expansion): Pass (The CTE of the ceramics shall not deviate by more than 0.5 x 10$^{-6}$ K$^{-1}$ from the value stated by the manufacturer.)
- Solubility: Pass (20 MPa zirconia material with at least one specified dental veneering ceramic)
- Thermal shock resistance: Pass (Meet critical quenching temperature of at least 120 °C)
Biocompatibility Testing:
A biological risk assessment was conducted, and the test results meet the requirements of the following ISO 10993 standard series:
- ISO 7405: 2018 Dentistry-Evaluation of biocompatibility of medical device used in dentistry
- ISO 10993-1:2018 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2021 Biological Evaluation of Medical Devices-Part 10: Test for Skin Sensitization
- ISO 10993-18:2020 Biological Evaluation of Medical Devices-Part 18: Chemical Characterization of Medical Device Within a Risk Management Process
- ISO 10993-23:2021 Biological Evaluation of Medical Device-Part 23: Test for Irritation
- USP Pvrogen Test (USP Rabbit Test)
Key results: Nonclinical testing data supports the conclusion that the proposed device performs as well as the primary predicates and reference devices. No human clinical studies were included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.
August 28, 2024
Dentsply Sirona Rebecca Sporer Principal Regulatory Affairs Specialist 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401
Re: K241557
Trade/Device Name: Cercon® yo ML Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 31, 2024 Received: May 31, 2024
Dear Rebecca Sporer:
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.
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"
1
(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 OS 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.
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-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.
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices
2
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
Cercon® yo ML
Indications for Use (Describe)
Cercon® yo ML is indicated in the anterior and posterior segments for:
-
Crowns
-
Multi-unit bridges (with a maximum of two pontics between abutment crowns)
-
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)
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4
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/4/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a blue abstract shape on the left and the words "Dentsply Sirona" in blue on the right. The abstract shape is made up of two curved lines that form an S shape. The words "Dentsply Sirona" are stacked on top of each other.
510(k) SUMMARY for Cercon® yo ML
1. Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17404
Contact Person: Rebecca Sporer Telephone Number: 717-849-4793 Email address: Rebecca.sporer@dentsplysirona.com
Date Prepared: 31 May 2024
-
- Device Name:
| Proprietary Name: | Cercon® yo ML |
|---|---|
| Classification Name: | Porcelain powder for clinical use |
| CFR Number: | 21 CFR 872.6660 |
| Device Class: | 2 |
| Product Code: | EIH |
-
- Predicate Device:
| Primary Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| Cercon | K162888 | Dentsply Sirona |
| Predicate Device Names | 510(k) | Company Name |
|---|---|---|
| CELTRA Press | K161269 | Dentsply Sirona |
| Cercon ht | K112152 | Dentsply Sirona |
| Reference Device Name
Technological Characteristics and
| Formulation | 510(k) | Company Name |
|---|---|---|
| CEREC Cercon 4D™ Abutment Blocks, | ||
| CEREC Cercon 4D™ Abutment System | K234018 | Dentsply Sirona |
5
4. Description of Device:
The proposed Cercon® yo ML is a partially sintered ceramic blank composed of yttrium oxide-(yttria-) stabilized zirconium oxide (zirconia) (Y-TZP). Cercon® yo ML is a multilayer disk built out of different shade layers and yttrium oxide contents which create a natural gradient of the restoration after sintering. The proposed device is supplied to dental professionals as a blank and then processed by machining and subsequent sintering to fabricate dental ceramic restorations.
5. Indications for Use:
Cercon® yo ML is indicated in the anterior and posterior segments for:
- Crowns
- · Multi-unit bridges (with a maximum of two pontics between abutment crowns)
- Inlays, onlays and veneers
-
- Comparison of Intended Use and Indications for Use and Technological Characteristics:
The Indications for Use of the proposed device do not constitute a new intended use. The proposed Cercon® yo ML has the same intended use and similar Indications for Use compared to the primary predicate and predicate devices in that they are a ceramic intended for fixed dental prosthetic restorations. Table 6.1 compares the Intended Use and Indications for Use when cared to the predicate devices.
6
| Table 6.1:Comparison of Intended Use and Indications for Use of the proposed and predicate devices | |||||
|---|---|---|---|---|---|
| Proposed Device | Primary Predicate | Predicate Devices | Discussion | ||
| Cercon® yo ML | |||||
| (K241557) | Device | ||||
| Cercon® | |||||
| (K162888) | CELTRA Press | ||||
| (K161269) | Cercon® ht | ||||
| (K112152) | |||||
| Intended Use | Cercon® yo ML blanks are a | ||||
| ceramic intended for fixed | |||||
| dental prosthetic restorations. | Cercon® are a ceramic | ||||
| intended for fixed dental | |||||
| prosthetic restorations. | CELTRA Press are a | ||||
| ceramic intended for | |||||
| fixed dental prosthetic | |||||
| restorations. | Cercon® ht are a | ||||
| ceramic intended for | |||||
| fixed dental prosthetic | |||||
| restorations. | Same | ||||
| Indications for | |||||
| Use | Cercon® yo ML is indicated | ||||
| for in the anterior and | |||||
| posterior segments for: | |||||
| • Crowns | |||||
| • Multi-unit bridges (with a | |||||
| maximum of two pontics | |||||
| between abutment crowns) | |||||
| • Inlays, onlays and veneers | Cercon® is indicated for | ||||
| all ceramic restorations | |||||
| for anterior and posterior | |||||
| locations, including | |||||
| crowns and 3-unit | |||||
| bridges in anterior and | |||||
| posterior regions. | Indications for Use: | ||||
| CELTRA Press is an all | |||||
| ceramic system for the | |||||
| creation of | |||||
| Occlusal veneers | |||||
| Thin veneers | |||||
| Veneers | |||||
| Inlays | |||||
| Onlays | |||||
| Crowns in the anterior | |||||
| and posterior region | |||||
| 3-unit bridges in the | |||||
| anterior | |||||
| and posterior region | |||||
| 3-unit bridges in the | |||||
| premolar region up to | |||||
| the second premolar as | |||||
| the terminal abutment | |||||
| Crown, splinted crown | |||||
| or 3 unit bridge up to | |||||
| the second premolar | |||||
| placed on top of an | |||||
| implant abutment. | Cercon® ht is | ||||
| indicated in the | |||||
| anterior and posterior | |||||
| segments for: | |||||
| • Crowns | |||||
| • telescopic primary | |||||
| crowns | |||||
| • multi-unit bridges | |||||
| (with no more the | |||||
| two pontics between | |||||
| abutment crowns) | The proposed, primary | ||||
| predicate, and predicate | |||||
| devices share the indication | |||||
| for crowns and bridges with | |||||
| applications in the anterior | |||||
| and posterior locations. |
The proposed, primary
predicate and predicate
devices share an indication
for multi-unit bridges (e.g. 3-
unit bridges).
The proposed and predicate
(Celtra Press [K161269])
devices are both indicated for
inlays, onlays and veneers.
The proposed device does not
include an indication for
telescopic primary crowns. |
7
7. Comparison of Technological Characteristics:
The proposed Cercon® yo ML is similar in design, principles of operation and meet the requirements of ISO 6872 when compared to the primary predicate device, Cercon (K16288), and the predicate devices, CELTRA Press (K161269) and Cercon ht (K112152). When comparing the material, the proposed, primary predicate (Cercon ht [K112152]) and reference devices are all zirconia material whereas the predicate (Celtra Press [K161269]) device is a lithium silicate glass material. The proposed Crcon® yo ML is similar in composition to the primary predicate (Cercon [K162888]), the predicate (Cercon ht [K112152]) and the reference (CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System [K234018]) devices with the main difference in pigment used for esthetics (shade preference). Table 7.1 compares the technological characteristics of the proposed, Cercon® yo ML to the predicates and reference devices.
Table 7.1:Technological Characteristics Comparison the proposed Cercon® yo ML, the primary predicate device Cercon® (K162888), predicates CELTRA Press (K161269) and Cercon® ht (K112152), and the reference device CEREC Cercon 4D™ Abutnent System (K234018)
| Item of | Proposed | Primary | Predicate Devices | Reference Device | Similarities and Differences | |
|---|---|---|---|---|---|---|
| Comparison | Cercon® yo ML | |||||
| (K241557) | Predicate | |||||
| Cercon® | ||||||
| (K162888) | CELTRA Press | |||||
| (K161269) | Cercon® ht | |||||
| (K112152) | CEREC Cercon | |||||
| 4DTM Abutment | ||||||
| Blocks, CEREC | ||||||
| Cercon 4DTM | ||||||
| Abutment System | ||||||
| (K234018) | ||||||
| Product Code | EIH | EIH | EIH | EIH | NHA, PNP | Similar. The reference device, |
| CEREC Cercon 4D Abutment | ||||||
| Blocks, CEREC Cercon 4DTM | ||||||
| Abutment System (K234018) is | ||||||
| cleared under a different product | ||||||
| code as it is marketed as a | ||||||
| system. The block material | ||||||
| within the system is processed | ||||||
| and compatible with implant | ||||||
| systems and TiBases. | ||||||
| Manufacturer | Dentsply Sirona | Dentsply Sirona | Dentsply Sirona | Dentsply Sirona | Dentsply Sirona | Same |
| Restoration | Single and multi- | |||||
| unit | Single and multi- | |||||
| unit | Single and multi- | |||||
| unit | Single and multi-unit | Single unit | Similar. The reference device, | |||
| CEREC Cercon 4D Abutment | ||||||
| Blocks, CEREC Cercon 4DTM | ||||||
| Abutment System (K234018) is | ||||||
| only used for single restorations. | ||||||
| Item of | Proposed | Primary | Predicate Devices | Reference Device | Similarities and Differences | |
| Comparison | Cercon® yo ML | |||||
| (K241557) | Predicate | |||||
| Cercon® | ||||||
| (K162888) | CELTRA Press | |||||
| (K161269) | Cercon® ht | |||||
| (K112152) | CEREC Cercon | |||||
| 4DTM Abutment | ||||||
| Blocks, CEREC | ||||||
| Cercon 4DTM | ||||||
| Abutment System | ||||||
| (K234018) | ||||||
| Material | Zirconia | Zirconia | Lithium silicate | |||
| glass | Zirconia | Zirconia | Same except when compared to | |||
| the predicate Celtra Press | ||||||
| (K161269) which is a lithium | ||||||
| silicate glass. | ||||||
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Biocompatibility | Meets ISO 10993 | |||||
| requirements | Meets ISO 10993 | |||||
| requirements | Meets ISO | |||||
| 10993 | ||||||
| requirements | Meets ISO 10993 | |||||
| requirements | Meets ISO 10993 | |||||
| requirements | Same | |||||
| Flexural Strength | >800 MPa per | |||||
| ISO 6872:2015 | ||||||
| Type II Class 5 | >500MPa per | |||||
| ISO 6872:2015 | ||||||
| Type II Class 4 | >500 MPa per | |||||
| ISO 6872:2015 | ||||||
| Type II Class 4 | >800MPa per ISO | |||||
| 6872:2008 Type II | ||||||
| Class 6 | >800 MPa per ISO | |||||
| 6872:2015 Type II | ||||||
| Class 5 | The proposed device has a | |||||
| higher flexural strength when | ||||||
| compared to the primary | ||||||
| predicate and the predicate | ||||||
| device, Celtra Press (K161269) | ||||||
| per the type and class defined in | ||||||
| ISO 6872:2015. The proposed | ||||||
| device is comparable in strength | ||||||
| to the predicate, Cercon ht | ||||||
| (K112152), and the reference | ||||||
| device, CEREC Cercon 4D | ||||||
| Abutment Blocks, CEREC | ||||||
| Cercon 4DTM Abutment System | ||||||
| (K234018). | ||||||
| Design | Disk | Disk | Ingot | Disk | Block | The proposed, primary predicate, |
| and the predicate [Cercon ht | ||||||
| (K112152)] devices are designed | ||||||
| as a disk. The predicate, Celtra | ||||||
| Item of | Proposed | |||||
| Cercon® yo ML | ||||||
| (K241557) | Primary | |||||
| Predicate | ||||||
| Cercon® | ||||||
| (K162888) | Predicate Devices | Reference Device | Similarities and Differences | |||
| Comparison | Image: Cercon yo ML | Image: Cercon xt | CELTRA Press | |||
| (K161269) | ||||||
| Image: CELTRA Press | Cercon® ht | |||||
| (K112152) | ||||||
| Image: Cercon ht | CEREC Cercon | |||||
| 4D™ Abutment | ||||||
| Blocks, CEREC | ||||||
| Cercon 4D™ | ||||||
| Abutment System | ||||||
| (K234018) | ||||||
| Image: CEREC Cercon 4D Abutment Blocks | press (K161269) is designed as | |||||
| an ingot and the refence device, | ||||||
| CEREC Cercon 4D Abutment | ||||||
| Blocks, CEREC Cercon 4D™ | ||||||
| Abutment System (K234018) is | ||||||
| a block. |
8
Table 7.1.Technological Characteristics Comparison between the primary predicate device Cercon® (K162888), predicates CELTRA Press (K161269) and Cercon® ht (K112152), and the reference device CEREC Cercon 4D™ Abutnent System (K234018)
9
Table 7.1:Technological Characteristics Comparison between the primary predicate device Cercon® (K162888), predicates CELTRA Press (K161269) and Cercon® ht (K112152), and the reference device CEREC Cercon 4D™ Abutnent System (K234018)
10
8. Non-Clinical Performance Data:
Performance Bench Testing:
The proposed device was tested and conforms to:
- ISO 6872:2015 Amd 1. 2018 Dentistry Ceramic Materials O
- 0 ISO 9693:2019 Dentistry Compatibility testing for metal-ceramic-ceramic-ceramic-ceramic systems
Table 8.1 summarizes the bench testing conducted on the proposed device according to ISO 6872:2015 Amd 1. 2018. Table 8.2 summarizes the bench testing conducted on the proposed device according to ISO 9693:2019.
| Table 8.1: Performance Bench Testing according to ISO 6872:2015 Amd. 1. 2018 | Test
Method/Applicable
Standard | Acceptance Criteria | Results |
|------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------|
| Flexural Strength | ISO 6872:2015 Amd 1.
2018 Dentistry Ceramic
Materials | $\geq$ 800 MPa | Pass |
| CTE (Coefficient of
Thermal Expansion) | | The CTE of the ceramics shall not
deviate by more than 0.5 x 10 $^{-6}$ K $^{-1}$ from
the value stated by the manufacturer. | Pass |
| Solubility | | 20 MPa zirconia material with at least
one specified dental veneering ceramic | Pass |
| Thermal shock resistance | for metal-ceramic and
ceramic-ceramic systems | Meet critical quenching temperature of
at least 120 °C | Pass |
11
Biocompatibility Testing:
A biological risk assessment was conducted on the proposed device, Cercon® yo ML. Review of available information on raw materials, manufacturing processes, chemical characterization tests and existing preclinical biological testing data concludes that the test results meet the requirements of the following ISO 10993 standard series.
The following biological tests were conducted:
- o ISO 7405: 2018 Dentistry-Evaluation of biocompatibility of medical device used in dentistry
- o ISO 10993-1:2018 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
- o ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro cytotoxicity
- o ISO 10993-10:2021 Biological Evaluation of Medical Devices-Part 10: Test for Skin Sensitization
- o ISO 10993-18:2020 Biological Evaluation of Medical Devices-Part 18: Chemical Characterization of Medical Device Within a Risk Management Process
- o ISO 10993-23:2021 Biological Evaluation of Medical Device-Part 23: Test for Irritation
- o USP Pvrogen Test (USP Rabbit Test)
Conclusion:
Minor differences in the technological characteristics between the proposed and primary predicate devices were evaluated through performance bench testing. Minor differences in formulation between the proposed, primary predicate, predicate [Cercon ht (K112152)] and reference devices was evaluated through biocompatibility testing. Testing results demonstrated that the proposed device does not raise new questions regarding safety and effectiveness. Therefore, the nonclinical testing data supports the conclusion that the proposed device performs as well as the primary predicates and reference devices.
-
- Clinical Performance Data:
No data from human clinical studies has been included to support the substantial equivalence of the proposed Cercon® yo ML.
- Clinical Performance Data:
10. Conclusion Regarding Substantial Equivalence:
Cercon® yo ML has the same intended use and similar Indications for Use as the primary predicate (Cercon [K16288]) and the predicates (Celtra Press [K161269] and Cercon ht [K112152]). Cercon® yo ML incorporates the same fundamental technology as the primary predicate (Cercon [K162888]) and the predicate (Cercon ht [K112152]) and the reference device (CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System [K234018]). The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well or better than the legally marketed primary predicate, predicates and reference devices.