(216 days)
Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structure of prostheses for partially edentulous patients in need of prosthetic oral reconstruction to restore chewing function and aesthetics.
The Additive Manufacturing Zirconia Customized Restoration is a premanufactured prosthetic component and is indicated for use as restorations (Crown, Bridge, Veneer, Inlay) that will be cemented to a natural or artificial tooth abutment.
Additive Manufacturing Zirconia Customized Restoration is an individualized dental restoration (Crown,Bridge,Veneer,Inlay) made from zirconia slurry.
Additive Manufacturing Zirconia Customized Restoration is intended to be a replacement for a natural tooth.After finalizing the Additive Manufacturing Zirconia Customized Restoration in the laboratory.t is cemented or bonded onto a tooth or artificial abutment, by a clinician,to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth.
To achieve esthetic and required value and chroma of the surrounding natural teeth the Additive Manufacturing Zirconia Customized Restoration is suitable for cut-back(veneering) or stain and glaze techniques.
The design of the Additive Manufacturing Zirconia Customized Restoration is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using or supported third party CAD systems. Once the restoration is ordered, it is sent electronically to Hangzhou Thales Medtech Co., Ltd. for fabrication.
The document provided is a 510(k) summary for a dental device, "Additive Manufacturing Zirconia Customized Restoration." It describes the device, its indications for use, and a comparison to predicate devices, along with performance and biocompatibility data to demonstrate substantial equivalence.
However, the provided text does not contain any information regarding a study involving human readers or AI assistance, or any performance data related to AI algorithms or human-in-the-loop performance. The performance data section refers to mechanical and biocompatibility testing of the physical dental restoration itself, not to the performance of any AI component.
Therefore, many of the requested details about acceptance criteria for AI performance, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance are not available in this document.
Below is a summary of the information that is present in the document.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally implied by adherence to ISO standards for dental ceramic materials. The performance values are reported in comparison to the predicate devices.
| Characteristic | Acceptance Criteria (Implied by ISO Standards) | Subject Device Performance | Predicate Device (K153534) Performance | Reference Device (K203072) Performance |
|---|---|---|---|---|
| Chemical Solubility (µg/cm²) | < 100 (ISO 6872) | < 100 | < 25 | < 25 |
| Fracture Toughness (MPa·√m) | Not explicitly stated beyond "SE" | 9.24 (Z-axis), 8.86 (X-axis) | Unknow | 6.44 |
| Thermal Expansion (um/m°C) | Not explicitly stated beyond "SE" | 10.80 | 10.80 | 9.95 |
| Biaxial Flexural Strength (MPa) (sintered) | ≥ 100 (ISO 6872, for Class 3) - Note: The full ISO 6872 classification and specific requirement for Class 3 materials like Y-TZP, often >800 or >1000 MPa, would be needed for a precise acceptance criterion here. 100 is generally a minimum for a broader class. The document states "meeting ISO 6872 requirements", implying compliance. | 1280 (46) (Means ± SD) | 1092 (112) (Means ± SD) | 1061 (Means ± SD) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for mechanical or biocompatibility testing, nor does it refer to a "test set" in the context of data for an AI/software device. The data provenance (country of origin, retrospective/prospective) is not mentioned for any of the performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is a physical dental restoration, not an AI or imaging device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The document describes a physical dental device; there is no mention of an AI component or MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical dental restoration, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical and biocompatibility testing, the "ground truth" is established by the relevant ISO standards and validated laboratory test methodologies. For example, for flexural strength, the ground truth is the measured force at fracture, evaluated against the standard's requirements.
8. The sample size for the training set
This information is not applicable. The device is a physical product, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable.
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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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
October 3, 2024
Hangzhou Thales Medtech Co., Ltd. % Chen Kaimin RA Beijing Xinranyicheng Medicine & Technology Co., Ltd. A-1109. Langqin International Building. No.168 Guang'anmen Outer Street, Xicheng District Beijing, Beijing 10053 China
Re: K240586
Trade/Device Name: Additive Manufacturing Zirconia Customized Restoration Regulation Number: 21 CFR 872.3920 Regulation Name: Porcelain Tooth Regulatory Class: Class II Product Code: ELL, EIH Dated: September 9, 2024 Received: September 9, 2024
Dear Chen Kaimin:
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"
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(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.
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 Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-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-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).
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Sincerely,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., 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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Additive Manufacturing Zirconia Customized Restoration
Indications for Use (Describe)
Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structure of prostheses for partially edentulous patients in need of prosthetic oral reconstruction to restore chewing function and aesthetics.
The Additive Manufacturing Zirconia Customized Restoration is a premanufactured prosthetic component and is indicated for use as restorations (Crown, Bridge, Veneer, Inlay) that will be cemented to a natural or artificial tooth abutment.
Type of Use (Select one or both, as applicable)
< Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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I. GENERAL INFORMATION
K240586
This 510(k) summary of substantial equivalence information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92.
Applicant:
Hangzhou Thales Medtech Co., Ltd. 1001Room 3# First Floor, 1Building, 8 Block Zhuantang Technological and Economic Zone, Xihu District, Hangzhou, Zhejiang Zip code:310000 CHINA Shuo Wang Phone:0086-18678195162 E-Mail:wangshuo@thalesmedtech.com Contact Person: Kaimin chen Phone:0086-15626286758
E-Mail:xinran159@xinranmed.com
Date Prepared: October 2, 2024
II. DEVICE INFORMATION
Trade Name: Additive Manufacturing Zirconia Customized Restoration Model:Additive manufacturing of zirconia porcelain crowns and bridges; Additive manufacturing of zirconia crowns and bridges; Additive manufacturing of zirconia porcelain veneers; Additive manufacturing of zirconia inlays Common Name : Porcelain tooth
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Classification Name: Porcelain Tooth
Regulation Number: 21 CFR 872.3920
Regulatory Class: Class II
Product Code: ELL
Classification Panel :Dental
Type of 510(k) submission: Traditional
PREDICATE DEVICE INFORMATION
Primary Predicate device : 510(K) Number:K153534 Company Name:Nobel Biocare Usa LLC Trade Name:NobelProcera HT ML Full Contour Zirconia Crown
Common Name:Porcelain Tooth
Product Code:ELL
Reference Device:
510(K) Number:K203072 Company Name:Franz Biotech Inc. Trade Name:Franz Zirconia Dental Crown Common Name:Porcelain Tooth Product Code:ELL
III. DEVICE DESCRIPTION
Additive Manufacturing Zirconia Customized Restoration is an individualized dental restoration (Crown,Bridge,Veneer,Inlay) made from zirconia slurry.
Additive Manufacturing Zirconia Customized Restoration is intended to be a replacement for a natural tooth.After finalizing the Additive Manufacturing Zirconia Customized Restoration in the laboratory.t is cemented or bonded onto a tooth or artificial abutment, by a clinician,to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth.
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To achieve esthetic and required value and chroma of the surrounding natural teeth the Additive Manufacturing Zirconia Customized Restoration is suitable for cut-back(veneering) or stain and glaze techniques.
The design of the Additive Manufacturing Zirconia Customized Restoration is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using or supported third party CAD systems. Once the restoration is ordered, it is sent electronically to Hangzhou Thales Medtech Co., Ltd. for fabrication.
IV. INDICATIONS FOR USE
Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structure of prostheses for partially edentulous patients in need of prosthetic oral reconstruction to restore chewing function and aesthetics.
The Additive Manufacturing Zirconia Customized Restoration is a premanufactured prosthetic component and is indicated for use as restorations (Crown,Bridge,Veneer,Inlay) that will be cemented to a natural or artificial tooth abutment.
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V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
| Description | Our Device | Predicate Device | Reference Device | Remark | ChemicalSolubility(µg/cm²) | <100(meeting ISO 6872requirements) | <25(meeting ISO 6872 requirements) | <25(meeting ISO 6872 requirements) | SE |
|---|---|---|---|---|---|---|---|---|---|
| Manufacturer | Hangzhou Thales Medtech Co., Ltd. | Nobel Biocare Usa LLC | Franz Biotech Inc. | -- | FractureToughness(MPa· $\sqrt{m}$ ) | 9.24(Z-axis)8.86(X-axis) | Unknow | 6.44 | SE |
| 510(k) Number | K240586 | K153534 | K203072 | -- | ThermalExpansion(um/m°C) | 10.80 | 10.80 | 9.95 | SE |
| Trade Name | Additive Manufacturing Zirconia Customized Restoration | NobelProcera HT ML Full Contour Zirconia Crown | Franz Zirconia Dental Crown | -- | Single Use | YES | YES | YES | SE |
| Indication for Use | Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structure of prostheses for partially edentulous patients in need of prosthetic oral reconstruction to restore chewing function and aesthetics.The Additive Manufacturing Zirconia Customized Restoration is a premanufactured prosthetic component and is indicated for use as restorations (Crown,Bridge,Veneer,Inlay) | NobelProcera HT ML FCZ Crown is indicated for use as core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.NobelProcera HT ML FCZ Crown is indicated for use as single crown that will be cemented to a natural or artificial tooth abutment. | Franz Zirconia Dental Crown is indicated for use as main structure of an artificial dental prothesis for partially edentulous patients which require prosthetic oral reconstruction to restore chewing function.Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment. | SE | Non-sterile | YES | YES | YES | SE |
| that will be cemented to anatural or artificial toothabutment. | Productiontype | 3D printing(AdditiveManufacturing; AM) | Nobel Biocare in-houseCAM | Franz biotech in-house3Dprinting (AdditiveManufacturing; AM) | A minor technological differencebetween the predicate device andsubject device was made by 3Dprint process, the predicate devicewas made by CNC. | ||||
| Numberofunits | CrownBridgeVeneerInlay | Individual crown | Individual crown | The number of units ofrestorations are different, but theK153534 and subject device areused in a similar anatomicallocation for a similarphysiological purpose. | |||||
| Material | Y-TZP Zirconium Oxide | Y-TZP Zirconium Oxide(Katana Zirconia K143439)KATANA Zirconia isused for the fabricationof the all-ceramicrestorations(frameworks, FCZ crowns, FCZ bridges,inlays, onlays and veneers.) | Y-TZP Zirconium Oxide | SE | |||||
| MinimumThickness | 0.3mm | 0.4mm (Anterior)0.7mm (Pre-molar and Molar) | 0.4mm (Anterior)0.7mm (Pre-molar and Molar) | SE | |||||
| BiaxialFlexuralStrength(MPa)(sintered) | Means±(SD)1280(46)(meeting ISO 6872requirements) | Means±(SD)1092(112)(meeting ISO 6872 requirements) | Means±(SD)1061(meeting ISO 6872requirements) | SE |
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Hangzhou Thales Medtech Co., Ltd. [Additive Manufacturing Zirconia Customized Restoration] 510(k) Submission
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Hangzhou Thales Medtech Co., Ltd. [Additive Manufacturing Zirconia Customized Restoration] 510(k) Submission
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VI. PERFORMANCE DATA
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use. The following tests were performed on the device.
• ISO 6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] Dentistry - Ceramic materials
· ISO 9693 Third edition 2019-10 Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
• ISO 22112 Second edition 2017-08 Dentistry - Artificial teeth for dental prostheses
VII. Biocompatibility testing
The biocompatibility evaluation and testing of the Additive Manufacturing Zirconia Customized Restoration was conducted in accordance with the following standards and guidance, as recognized by the FDA:
- · ISO 10993-1:2018(en) Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- · ISO 10993-3:2014, Biological evaluation of medical device-Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity.
- · ISO 10993-5:2009, Biological evaluation of medical device-Part 5: Tests for in vitro cytotoxicity.
- · ISO 10993-10:2010, Biological evaluation of medical device-Part 10: Tests for irritation and skin sensitization.
- · ISO 10993-11:2017, Biological evaluation of medical device-Part 11: Tests for systemic toxicity.
- · ISO 10993-12:2012, Biological evaluation of medical device-Part 12: Sample preparation and reference materials.
Biocompatibility testing of the subject device:
| No. | Standard | Test Item |
|---|---|---|
| 1 | ISO 10993-5:2009 | Cytotoxicity |
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| 2 | ISO 10993-10:2010 | Sensitization |
|---|---|---|
| 3 | ISO 10993-10:2010 | Irritation |
| (including intracutaneous reactivity) | ||
| 4 | ISO 10993-11:2017 | Acute systemic toxicity |
| 5 | ISO 10993-11:2017 | Subchronic toxicity |
| 6 | ISO 10993-3:2014 | Bacterial reverse mutation assay |
| 7 | ISO 10993-3:2014 | TK Gene Mutation Test |
| 8 | ISO 10993-3:2014 | Chromosome Aberration Test |
VIII. Mechanical testing
Additive -Manufacturing Zirconia Customized Restoration's mechanical function including Radioactivity Test, Flexural strength, Linear thermal expansion coefficient test ,Fracture toughness tests and other tests which were tested and demonstrated that the design specification from design input are fulfilled. Mechanical safety tests were also conducted to demonstrate that the reliability of the device for during use no safety concern.
No animal studies or clinical testing have been required for these devices.
IX. Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to the predicate device, the Additive Manufacturing Zirconia Customized Restoration has all features of predicate devices. The differences between them do not raise new question of safety and effectiveness. Thus,the subject device is substantially equivalent to the predicate device.
§ 872.3920 Porcelain tooth.
(a)
Identification. A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.(b)
Classification. Class II.