(88 days)
Not Found
No
The device description and performance studies focus solely on the material composition and mechanical properties of dental zirconia blanks, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The devices are raw materials (blanks) used for creating dental restorations, not the finished therapeutic devices themselves. They are processed by dental professionals into products like crowns and bridges, which then serve a therapeutic function.
No
This device is a material (zirconia blanks) used for fabricating dental restorations (e.g., crowns, bridges), not for diagnosing medical conditions. Its use is in manufacturing physical devices, not in assessing patient health or disease.
No
The device description clearly states it is a physical product (zirconia blanks) made from powder and processed into shapes for dental restorations. It does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating dental restorations (crowns, bridges, etc.) using CAD/CAM or manual milling machines. This is a manufacturing process for a medical device that will be implanted or used in the mouth.
- Device Description: The device is a blank made of zirconia powder, which is then fabricated into dental restorations. This describes a material used in the creation of a medical device.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or treat a disease or condition by examining specimens derived from the human body. IVDs are typically used to analyze blood, urine, tissue, or other bodily fluids or samples.
The device is a material used in the fabrication of dental prosthetics, which are considered medical devices, but not IVDs.
N/A
Intended Use / Indications for Use
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are derived from zirconia powder that has been processed into their final shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+ Y2O3+ HfO2+ Al2O3 with its composition conforms to ISO 13356, Implants for surgery – Ceramic materials based on vttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are derived from the same Zirconia powder as the regular Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank with the addition of very small amount of inorganic pigments before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental laboratories or by 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)
Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the Dental Zirconia Blank met its specifications. All tests were verified to meet acceptance criteria. Test results on radioactivity, flexural strength, chemical solubility, linear thermal expansion coefficient, freedom from extraneous materials, uniformity, shrinkage factor, pre-sintered density, sintered density, and fracture toughness of the subject device are very similar to predicate device. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The biocompatibility testing results for the proposed device are as follows:
- Cytotoxicity (ISO 10993-5:2009): Pass (non cytotoxic for 2h and 24h in filter diffusion, accepted in agar diffusion, no potential toxicity to L-929 cells)
- Oral Mucosa Irritation (ISO 10993-23:2021): Pass (no potential oral mucosa irritation in Syrian hamsters)
- Skin Sensitization Test (ISO 10993-10:2021): Pass (no evidence of causing delayed dermal contact sensitization in guinea pig)
- Subacute Toxicity Test (ISO 10993-11:2017) and Subacute Systemic Toxicity Test (ISO 10993-11:2017): Pass (did not induce subacute systemic toxicity in rats)
- Acute Systemic Toxicity (ISO 10993-11:2017): Pass (no evidence of causing acute system toxicity in ICR mice)
- In Vitro Mammalian Cell Gene Mutation Test (ISO 10993-3:2014): Pass (considered non-mutagenic)
- In vitro Mammalian Chromosome Aberration Test (ISO 10993-3:2014): Pass (did not induce structural chromosome aberrations in cultured CHL cells)
- Bacterial Reverse Mutation Test (ISO 10993-3:2014): Pass (no potential mutagenesis)
- Muscle Implant (ISO 10993-6:2016): Pass (did not induce local effects after implantation of biomaterials in rabbits)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6660 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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
June 7, 2024
Zhejiang Zahndent Biotechnology Co., Ltd % Shangfeng Jiang Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 304, Building A, No. 62 Nanyun 2nd Road Science Town, Huangpu District Guangzhou City, Guangdong 510663 China
Re: K240672
Trade/Device Name: Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: March 11, 2024 Received: March 11, 2024
Dear Shangfeng Jiang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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
2
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
Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (ZD-HT-PLUS, ZD-ST, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)
Indications for Use (Describe)
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
Type of Use (Select one or both, as applicable)
1XPrescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary - K240672
Date of Summary Preparation: February 20, 2024
1. Submitter's Identifications
Submitter's Name: Zhejiang Zahndent Biotechnology Co.,Ltd Address: #203,Building 8,Lecheng Industrial Park, Xingian, HuangYan District, 318020 Taizhou, Zhejiang Province, China Zip Code: 318020 Contact Person: Yaping Huang Contact Title: General Manager Contact E-mail Address: Claire(@zahndent.com Tel: +86-576-84203176
2. Correspondent's Identifications
Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town, Huangpu District, Guangzhou City, Guangdong, 510663, China ZIP Code: 510663 Contact Person: Shanfeng Jiang Contact Title: Regulation Control Manager Contact E-mail Address: jiang13620586569@126.com Tel: +86-20-82329549 Fax: +86-20-82329549
3. Name of the Device
Device Classification Name: Powder, Porcelain Regulation Description: Porcelain powder for clinical use Trade Name: Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Model: ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML. Regulation Medical Specialty: Dental Review Panel: Dental Product Code: EIH Regulation Number: 21 CFR 872.6660 Device Classification: Class II
4. The Predicate Devices
Predicate device: K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Liaoning Upcera Company Limited
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5. Device Description
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are derived from zirconia powder that has been processed into their final shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+ Y2O3+ HfO2+ Al2O3 with its composition conforms to ISO 13356, Implants for surgery – Ceramic materials based on vttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are derived from the same Zirconia powder as the regular Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank with the addition of very small amount of inorganic pigments before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
6. Intended Use of Device
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
7. Summary of Substantial Equivalence
| Proposed Device | Predicate device | Comparison | |
|---|---|---|---|
| 510k Number | K141724 | ------ | |
| Product Code | EIH | EIH | Same |
| Proprietary Name | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | ------ |
| Model: | ZD-HT-PLUS, | ||
| ZD-ST, ZD-SHT, | |||
| ZD-HT-C, ZD-ST-C, | |||
| ZD-SHT-C, | |||
| ZD-UT-C, | |||
| ZD-ST-ML, | |||
| ZD-SHT-ML, | |||
| ZD-UT-ML, | |||
| ZD-3D-Pro-ML | ------ | ------ | |
| ZD-4D-Pro-ML. | |||
| Manufacturer | Zhejiang Zahndent | ||
| Biotechnology | |||
| Co.,Ltd | Liaoning Upcera | ||
| Company Limited | ----- | ||
| Indications for | |||
| Use | Dental Zirconia | ||
| Blank & Dental | |||
| Zirconia | |||
| Pre-Shaded Blank | |||
| are used for dental | |||
| restorations using | |||
| different | |||
| CAD/CAM or | |||
| manual milling | |||
| machines. All | |||
| blanks are | |||
| processed through | |||
| dental laboratories | |||
| or by dental | |||
| professionals. | Upcera Dental | ||
| Zirconia Blank & | |||
| Dental Zirconia | |||
| Pre-Shaded Blank | |||
| are used for dental | |||
| restorations using | |||
| different | |||
| CAD/CAM or | |||
| manual milling | |||
| machines. All | |||
| blanks are | |||
| processed though | |||
| dental laboratories | |||
| or by dental | |||
| professionals. | Same | ||
| Basic design | Blocks, and rods | Blocks, disc, and | |
| rod | Same | ||
| Materials | Regular: | ||
| Zirconia (ZrO2+ | |||
| Y2O3+ HfO2+ | |||
| $Al2O3≥99.0%$ ) |
Pre-shaded:
Zirconia (ZrO2+
Y2O3+ HfO2+
$Al2O3≥99.0%$ )
Inorganic pigments
(Fe2O3, Er2O3 and
MnO