Additive Manufacturing Zirconia Customized Restoration
Device Facts
| Record ID | K240586 |
|---|---|
| Device Name | Additive Manufacturing Zirconia Customized Restoration |
| Applicant | Hangzhou Thales Medtech Co., Ltd. |
| Product Code | ELL · Dental |
| Decision Date | Oct 3, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3920 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Device is an individualized dental restoration (crown, bridge, veneer, inlay) fabricated from Y-TZP zirconium oxide slurry via additive manufacturing (3D printing). Design is performed in dental labs/clinics using third-party CAD systems; digital files are sent to manufacturer for fabrication. Finalized restorations are cemented/bonded by clinicians onto natural or artificial tooth abutments to restore chewing function and aesthetics. Suitable for cut-back (veneering) or stain and glaze techniques. Benefits include patient-specific anatomical fit and restoration of oral function.
Clinical Evidence
No clinical data or animal studies were performed. Substantial equivalence is supported by bench testing, including mechanical property testing (flexural strength, fracture toughness, thermal expansion) and biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, and genotoxicity) per ISO standards.
Technological Characteristics
Material: Y-TZP Zirconium Oxide. Fabrication: Additive manufacturing (3D printing). Minimum thickness: 0.3mm. Biaxial flexural strength: 1280 MPa. Thermal expansion: 10.80 um/m°C. Fracture toughness: 9.24 (Z-axis) / 8.86 (X-axis) MPa·m^1/2. Non-sterile, single-use. Complies with ISO 6872, ISO 9693, and ISO 22112.
Indications for Use
Indicated for partially edentulous patients requiring prosthetic oral reconstruction to restore chewing function and aesthetics. Used as core structure for crowns, bridges, veneers, and inlays cemented to natural or artificial tooth abutments.
Regulatory Classification
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.
Predicate Devices
- NobelProcera HT ML Full Contour Zirconia Crown (K153534)
Reference Devices
- Franz Zirconia Dental Crown (K203072)
Submission Summary (Full Text)
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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)
K240586
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)
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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 | Chemical<br>Solubility<br>(µg/cm²) | <100<br>(meeting ISO 6872<br>requirements) | <25<br>(meeting ISO 6872 requirements) | <25<br>(meeting ISO 6872 requirements) | SE |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|--------------------------------------------|----------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hangzhou Thales Medtech Co., Ltd. | Nobel Biocare Usa LLC | Franz Biotech Inc. | -- | Fracture<br>Toughness<br>(MPa· $\sqrt{m}$ ) | 9.24(Z-axis)<br>8.86(X-axis) | Unknow | 6.44 | SE |
| 510(k) Number | K240586 | K153534 | K203072 | -- | Thermal<br>Expansion<br>(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.<br>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.<br>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.<br>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 a<br>natural or artificial tooth<br>abutment. | | | | Production<br>type | 3D printing(Additive<br>Manufacturing; AM) | Nobel Biocare in-house<br>CAM | Franz biotech in-house<br>3Dprinting (Additive<br>Manufacturing; AM) | A minor technological difference<br>between the predicate device and<br>subject device was made by 3D<br>print process, the predicate device<br>was made by CNC. |
| Number<br>of<br>units | Crown<br>Bridge<br>Veneer<br>Inlay | Individual crown | Individual crown | The number of units of<br>restorations are different, but the<br>K153534 and subject device are<br>used in a similar anatomical<br>location for a similar<br>physiological purpose. | | | | | |
| Material | Y-TZP Zirconium Oxide | Y-TZP Zirconium Oxide<br>(Katana Zirconia K143439)<br>KATANA Zirconia is<br>used for the fabrication<br>of the all-ceramic<br>restorations<br>(frameworks, FCZ crowns, FCZ bridges,<br>inlays, onlays and veneers.) | Y-TZP Zirconium Oxide | SE | | | | | |
| Minimum<br>Thickness | 0.3mm | 0.4mm (Anterior)<br>0.7mm (Pre-molar and Molar) | 0.4mm (Anterior)<br>0.7mm (Pre-molar and Molar) | SE | | | | | |
| Biaxial<br>Flexural<br>Strength<br>(MPa)(sintere<br>d) | Means±(SD)<br>1280(46)<br>(meeting ISO 6872<br>requirements) | Means±(SD)<br>1092(112)<br>(meeting ISO 6872 requirements) | Means±(SD)<br>1061<br>(meeting ISO 6872<br>requirements) | 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.
