(66 days)
No
The summary describes a material block for CAD/CAM milling and does not mention any software or algorithms that would incorporate AI/ML.
No
The device, CEREC Cercon 4D™ CAD/CAM Blocks, is a material used to fabricate dental restorations (crowns, bridges, inlays, onlays, veneers). It is an intermediate product that requires further processing (milling, sintering, polishing, glazing) by dental professionals before it becomes a finished device that is inserted into a patient's mouth. Therefore, it is a material used in the creation of therapeutic devices, but not a therapeutic device itself.
No
The device description clearly states that these are pre-sintered zirconia blocks for CAD/CAM milling, designed for the fabrication of dental restorations (crowns, bridges, inlays, onlays, veneers). They are materials to be further processed, not a tool for diagnosis.
No
The device description clearly states it is a pre-sintered zirconia block, which is a physical material used for milling dental restorations. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fabricating dental restorations (crowns, bridges, inlays, onlays, veneers) for placement in a patient's mouth. This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The device is a material (zirconia block) used to create a finished dental restoration. It is not used to test a sample from the human body to provide information about a physiological state, health, or disease.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples, detect markers, or provide any diagnostic information.
- Performance Studies: The performance studies focus on the material's physical properties, biocompatibility, and suitability for creating dental restorations, not on diagnostic accuracy or performance.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. This device is a material used to create a medical device (a dental restoration) that is placed in vivo (inside the body).
N/A
Intended Use / Indications for Use
Indications for CEREC Cercon 4D CAD/CAM Blocks are:
- -Crowns and bridges in the posterior and anterior tooth region
- Bridges with a maximum of two pontics
- Inlays, onlays and veneers
Product codes
EIH
Device Description
CEREC Cercon 4D™ CAD/CAM Block are pre-sintered zirconia blocks composed of yttria stabilized zirconia, which are designed for CAD/CAM milling. The proposed CEREC Cercon 4D™ CAD/CAM Blocks possess a 3-dimensional contour of dentine powder to mimic the natural tooth build-up. The aim of the 3D contour technology is to achieve more aesthetic restorations than with blocks based on the current multi-layer technology.
The CEREC Cercon 4D™ CAD/CAM Blocks are used for fabrication of a dental restoration. The CEREC Cercon 4D™ CAD/CAM Blocks are not provided as the finished, fully finished dental restoration. The blocks are single use, meaning that they can only be milled once and are not recommended for re-milling. The blocks are materials supplied to dental professionals that must be further processed/manufactured using CAD/CAM milling and subsequent sintering to fabricate all ceramic restorations and they are not intended to be reused as in the context of direct patient-applied devices and materials. Therefore, no reprocessing, cleaning or disinfection instructions apply because it is a dental material and not a finished dental restoration itself. After sintering of the restoration, the dental professional will finish the restoration via polishing or glazing, before insertion into the patient's mouth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior and anterior tooth region
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 CEREC Cercon 4D™ CAD/CAM Blocks was tested and conforms to:
- ISO 6872:2015 Amd 1. 2018 Dentistry Ceramic Materials O
- ISO 9693:2019 Dentistry Compatibility testing for metal-ceramic and ceramic-ceramic O systems
Table 8.1: Performance Bench Testing according to ISO 6872:2015 Amd. 1. 2018
- Test Performed: Flexural Strength, Results: Pass
- Test Performed: CTE (Coefficient of Thermal Expansion), Results: Pass
- Test Performed: Solubility, Test Method/Applicable Standard: ISO 6872:2015 Amd 1. 2018 Dentistry Ceramic Materials, Results: Pass
- Test Performed: Radioactivity, Results: Pass
- Test Performed: Shrinkage factor, Test Method/Applicable Standard: Class 5 Type II material, Results: Pass
- Test Performed: Uniformity, Results: Pass
- Test Performed: Freedom from extraneous materials, Results: Pass
Table 8.2: Performance Bench Testing according to ISO 9693:2019
- Test Performed: De-bonding / crack-initiation, Test Method/Applicable Standard: ISO 9693:2019 Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems, Results: Pass
- Test Performed: Thermal shock resistance, Test Method/Applicable Standard: testing for metal-ceramic and ceramic-ceramic systems, Results: Pass
Biocompatibility Testing:
A biological risk assessment was conducted. Tests were performed according to:
- ISO 7405: 2018 Dentistry-Evaluation of biocompatibility of medical device used in dentistry
- ISO 10993-1:2018 Biological evaluation of medical devices-Part I: 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 Pyrogen Test (USP Rabbit Test)
Key Results: Testing results demonstrated that the proposed CEREC Cercon 4D™ CAD/CAM Blocks does not raise new questions regarding safety and effectiveness. The nonclinical testing data supports that the CEREC Cercon 4D™ CAD/CAM Block is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue box, and the full name is in a sans-serif font.
October 24, 2024
Dentsply Sirona Rebecca Sporer Principal Regulatory Affairs Specialist 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401
Re: K242462
Trade/Device Name: CEREC Cercon 4D CAD/CAM Blocks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: August 19, 2024 Received: August 19, 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 (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 medical devices and radiation-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-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,
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
3
Indications for Use
Submission Number (if known)
Device Name
CEREC Cercon 4D CAD/CAM Blocks
Indications for Use (Describe)
Indications for CEREC Cercon 4D CAD/CAM Blocks are:
- -Crowns and bridges in the posterior and anterior tooth region
- Bridges with a maximum of two pontics
- 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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Image /page/4/Picture/0 description: The image contains the logo for Dentsply Sirona. The logo consists of a blue abstract shape on the left, resembling a stylized leaf or wave. To the right of the shape are the words "Dentsply" and "Sirona" stacked vertically, also in blue. The overall design is clean and modern, reflecting the company's branding.
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
K242462 - 510(k) SUMMARY for CEREC Cercon 4D™ CAD/CAM Blocks
-
- Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W
York, PA 17401
- Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W
| Contact Person: | Rebecca Sporer |
|---|---|
| Telephone Number: | 717-849-4793 |
| Email: | rebecca.sporer@dentsplysirona.com |
| Date Prepared: | 15 October 2024 |
2. Device Name:
- CEREC Cercon 4D™ CAD/CAM Blocks Trade Name: ●
- Common Name: Zirconia Blocks ●
- Porcelain powder for clinical use ● Classification Name:
- CFR Number: 872.6660 ●
- Device Class: Class II
- Primary Product Code: EH
3. Predicate/Reference Devices:
| Primary Predicate Device | 510(k) | Company Name |
|---|---|---|
| inCoris TZI | K123545 | Dentsply Sirona |
| Predicate Device | ||
| KATANA Zirconia Block | K190436 | Kuraray Noritake |
| Dental Inc. |
| Reference Device Name | 510(k) | Company Name |
|---|---|---|
| CEREC Cercon 4DTM Abutment Block, CEREC Cercon | ||
| 4DTM Abutment System | K234018 | Dentsply Sirona |
| Cercon | K162888 | Dentsply Sirona |
4. Description of Device:
CEREC Cercon 4D™ CAD/CAM Block are pre-sintered zirconia blocks composed of yttria stabilized zirconia, which are designed for CAD/CAM milling. The proposed CEREC Cercon 4D™ CAD/CAM Blocks possess a 3-dimensional contour of dentine powder to mimic the natural tooth build-up. The aim of the 3D contour technology is to achieve more aesthetic restorations than with blocks based on the current multi-layer technology.
5
The CEREC Cercon 4D™ CAD/CAM Blocks are used for fabrication of a dental restoration. The CEREC Cercon 4D™ CAD/CAM Blocks are not provided as the finished, fully finished dental restoration. The blocks are single use, meaning that they can only be milled once and are not recommended for re-milling. The blocks are materials supplied to dental professionals that must be further processed/manufactured using CAD/CAM milling and subsequent sintering to fabricate all ceramic restorations and they are not intended to be reused as in the context of direct patient-applied devices and materials. Therefore, no reprocessing, cleaning or disinfection instructions apply because it is a dental material and not a finished dental restoration itself. After sintering of the restoration, the dental professional will finish the restoration via polishing or glazing, before insertion into the patient's mouth.
5. Indications for Use:
Indications for CEREC Cercon 4D™ CAD/CAM Blocks are:
- · Crowns and bridges in the posterior and anterior tooth region.
- · Bridges with a maximum of two pontics
- · Inlays, onlay and veneers
-
- Substantial Equivalence:
The Indications for Use of the proposed device is similar to the primary predicate and predicate devices. Refer to Table 6.1 for a comparison.
| Table 6.1-Comparison of Indications for Use | |||
|---|---|---|---|
| Proposed Device | |||
| CEREC Cercon 4DTM | |||
| CAD/CAM Blocks | Primary Predicate | ||
| Device | |||
| inCoris TZI | |||
| (K123545) | Predicate Device | ||
| KATANA Zirconia | |||
| Blocks | |||
| (K190436) | Discussion | ||
| Indications for CEREC | |||
| Cercon 4DTM CAD/CAM | |||
| Blocks are: | |||
| • Crowns and bridges in | |||
| the posterior and | |||
| anterior tooth region | |||
| • Bridges with a | |||
| maximum of two pontics | |||
| • Inlays, onlays and | |||
| veneers | Classic and Speed | ||
| Sintering: | |||
| Fully anatomic crowns | |||
| and bridges in the | |||
| posterior and anterior | |||
| tooth regions. Bridges | |||
| with maximum two | |||
| pontics. | |||
| Super Speed Sintering: | |||
| Fully anatomic crowns. | KATANA Zirconia | ||
| Blocks is used for the | |||
| fabrication of the | |||
| ceramic restorations | |||
| (frameworks, FCZ | |||
| crowns, FCZ bridges | |||
| (14Z L), inlays, | |||
| onlays and veneers). | The proposed and primary | ||
| predicate have similar | |||
| Indications for Use. They | |||
| both are indicated for crowns | |||
| and bridges in the posterior | |||
| and anterior tooth regions | |||
| and bridges with maximum | |||
| of two pontics. | |||
| The proposed and predicate | |||
| have similar indications for | |||
| crowns, bridges, inlay, | |||
| onlays and veneers. |
6
7. Technological Characteristics:
The proposed CEREC Cercon 4D™ CAD/CAM Blocks are similar in Indications for Use, design and principles of operation when compared to the primary predicate, inCoris TZi (K123545) and the predicate. KATANA Ziroonia Block (K190436). Table 7.1 compares the technological characteristics of the proposed device compared to the primary predicate devices.
Table 7.1 Comparison between the proposed CEREC Cercon 4D" CAD/CAM Blocks, the primary predicate device inCoris TZI (K123545) and predicate device KATANA Zirconia Block (K190436)
| Item of
Comparison | Proposed Device
CEREC Cercon 4D™
CAD/CAM Blocks | Primary Predicate Device
inCoris TZI
(K123545) | Predicate Device
KATANA Zirconia Block
(K190436) | Similarities and Differences |
|-----------------------|-------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | EIH | EIH | EIH | Same |
| Manufacturer | Dentsply Sirona | Dentsply Sirona | Kuraray Noritake Dental Inc. | The proposed and primary predicate
devices are manufactured at different
Dentsply Sirona (owner/ operator)
facilities. The predicate device is a
competitor product. |
| Restoration | Crowns, Bridges, Inlays, Onlays
or Veneers | Crowns or Bridges | Crowns, Bridges, Inlays, Onlays
or Veneers | Similar. The proposed and predicate
device are indicated for the fabrication of
the same type of restorations. The
primary predicate is only indicated for
crowns and bridges. |
| Material | Zirconia | Zirconia | Zirconia | Same. The proposed, primary predicate
and predicate devices are all zirconia
material. |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Biocompatibility | Meets ISO 10993 requirements | Meets ISO 10993 requirements | Meets ISO 10993 requirements | Same |
| Design | Image: CEREC Cercon 4D CAD/CAM Block | Image: inCoris TZI Block | Image: KATANA Zirconia Block | Same.
The proposed and predicate devices are
all shaped like a block |
7
The reference devices, CEREC Cercon 4D™ Abutment Block, CEREC Cercon 4D™ Abutment System (K234018) and Cercon (K162888) are included to support the composition of the block material. The composition of the proposed device is similar to the composition of the reference devices, CEREC Cercon 4D™ Abutment Block, CEREC Cercon 4D™ Abutment System (K234018) and Cercon (K162888). The main difference in composition is the yttrium oxide ranges due to the 3-dimensional contour of dentine powder to mimic the natural tooth build-up which achieves a more aesthetic restorations based on the multi-layer technology. The proposed and reference devices both contain pigments for shading esthetics.
-
- Non-Clinical Performance Data:
Performance Bench Testing:
The proposed CEREC Cercon 4D™ CAD/CAM Blocks was tested and conforms to:
- ISO 6872:2015 Amd 1. 2018 Dentistry Ceramic Materials O
- ISO 9693:2019 Dentistry Compatibility testing for metal-ceramic and ceramic-ceramic O 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 Performed | Test Method/Applicable Standard | Results |
| Flexural Strength | Pass | |
| CTE (Coefficient of Thermal Expansion) | Pass | |
| Solubility | ISO 6872:2015 Amd 1. 2018 Dentistry | |
| Ceramic Materials | Pass | |
| Radioactivity | Pass | |
| Shrinkage factor | Class 5 Type II material | Pass |
| Uniformity | Pass | |
| Freedom from extraneous materials | Pass |
| Table 8.2: Performance Bench Testing according to ISO 9693:2019 | ||
|---|---|---|
| Test Performed | Test Method/Applicable Standard | Results |
| De-bonding / crack-initiation | ISO 9693:2019 Dentistry - Compatibility | |
| testing for metal-ceramic and ceramic-ceramic systems | Pass | |
| Thermal shock resistance | testing for metal-ceramic and ceramic- | |
| ceramic systems | Pass |
8
Biocompatibility Testing:
A biological risk assessment was conducted on the proposed device, CEREC Cercon 4D™ CAD/CAM Blocks. 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 I: 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 Pyrogen Test (USP Rabbit Test)
Conclusion:
Minor differences in the technological characteristics between the proposed, primary predicate, predicate and reference devices were evaluated through performance bench testing. Minor differences in formulation between the proposed and reference device, was evaluated through biocompatibility testing. Testing results demonstrated that the proposed CEREC Cercon 4D™ CAD/CAM Blocks does not raise new questions regarding safety and effectiveness. The nonclinical testing data supports that the CEREC Cercon 4D™ CAD/CAM Block is substantially equivalent to the predicate devices.
-
- Clinical Performance Data:
No data from human clinical studies has been included to support the substantial equivalence of the proposed CEREC Cercon 4D™ CAD/CAM Blocks.
- Clinical Performance Data:
10. Conclusion Regarding Substantial Equivalence:
CEREC Cercon 4D™ CAD/CAM Blocks have similar Indications for Use as the primary predicate and the predicate devices. CEREC Cercon 4D™ CAD/CAM Blocks incorporates the same fundamental technology as the primary predicate and predicate devices. The composition of the proposed CEREC Cercon 4D™ CAD/CAM Blocks is similar to the composition of the reference devices. Test data is included in this premarket notification to verify the safety and performance requirements of the proposed device and the results support a conclusion of substantial equivalence.