(58 days)
Not Found
No
The summary describes a material (zirconia blocks) used in CAD/CAM processes for dental restorations. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on material properties and biocompatibility.
No
This device is a material (zirconia blocks) used to fabricate dental restorations, which are prosthetic devices, not therapeutic devices. It replaces a missing body part, which is a prosthetic function, not a therapeutic one.
No
This device is a material (zirconia blocks) used to fabricate dental restorations, not to diagnose a condition.
No
The device description clearly states that the device is a physical material (zirconia blocks) used in the fabrication of dental restorations. It is not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce dental restorations (artificial teeth, crowns, etc.) using CAD/CAM technology. This is a manufacturing process for a medical device (the dental restoration), not a diagnostic test performed on a biological sample.
- Device Description: The description details the composition and processing of a material (zirconia) used to create dental prosthetics. It does not describe a device used to analyze biological samples or provide diagnostic information.
- Lack of Diagnostic Function: The device's function is to be shaped and sintered into a dental restoration. It does not interact with or analyze biological samples to provide diagnostic results.
- Performance Studies: The performance studies focus on the material properties of the zirconia block (strength, solubility, etc.) and its biocompatibility, which are relevant to its use as a dental restorative material, not a diagnostic device.
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 the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
"Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" is intended for use with CAD/CAM technology to produce all ceramic dental restorations as prescribed by a dentist. 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 Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" is derived from zirconia powder that has been processed through various molding and sintering techniques – into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. The zirconia powder is composed of ZrO2, Y2O3, HfO2 and other oxides. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.
"Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" is ceramic dental blanks designed for the manufacture of ceramic dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.
"Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" is supplied in different shapes, such as blocks, disc, and semi-disc, or customer ordered shapes. It is also supplied in the combinations of 21 different colors, and single and multi-layer aesthetic effect.
The different colors are originated from the different constituent of color additives (such as Fe>O3, Er>O3); and the multilayer aesthetic effect is originated from the different padding method used in the process of dry pressing.
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 6872:2008 and internal procedures to ensure that the "Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" met its specifications.
The following tests were performed: Uniformity Freedom from Extraneous Materials Radioactivity Shrinkage factor Sintered Density before Sintering Sintered Density after Sintering Expansion Coefficient Sintered Flexural Strength Chemical Solubility Vickers hardness
All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalence of the materials that are used.
Per FDA's guidance document entitled "Use of International Standard ISO 10993-1, `Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,"", as well as ISO 10993-1: 2018, the following biocompatibility endpoints are considered:
Cytotoxicity (ISO 10993-5) Irritation & Sensitization (ISO 10993-10) Acute Systematic Toxicity (ISO 10993-11) Subacute Subchronic Systematic Toxicity (ISO 10993-11) Material Mediated Pyrogenicity (ISO 10993-11) Implantation (ISO 10993-6) Chronic Systematic Toxicity (ISO 10993-11) Genotoxicity (ISO 10993-3) Carcinogenicity (ISO 10993-3)
Biocompatibility was evaluated per ISO 19993-1: 2009, and it was found that the subject device is as biocompatible as the predicate device.
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.
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 symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
May 31, 2024
Anhui Miisen Intelligence Technology Co., Ltd. % Jinfeng Ning Manager Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436
Re: K240912
Trade/Device Name: Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 3, 2024 Received: April 3, 2024
Dear Jinfeng Ning:
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).
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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
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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
Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
"Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" is intended for use with CAD/CAM technology to produce all ceramic dental restorations as prescribed by a dentist. All blanks are processed through dental laboratories or by dental professionals
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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K240912 510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
5.1 Submitter & Foreign Manufacture Identification
Anhui Miisen Intelligence Technology Co., Ltd. January 14, 2024 No. 6 Building, South Huoyanshan Road, Economic Development, Zone Fanchang District, Wuhu City, Anhui Province, China Tel: (086)- 0553-2358187 Submitter's FDA Registration Number: N/A
5.2 Contact Person
Image /page/4/Picture/5 description: The image shows a logo with Chinese characters and a stylized letter "M". The letter "M" is formed by two triangular shapes with a blue, textured fill. Above the "M" is a curved, light blue shape that resembles a crescent. To the left of the crescent, there are two Chinese characters in orange. The logo appears to represent a company or organization, possibly in the medical or healthcare field, given the presence of the Chinese characters and the overall design.
Primary Contact Person Jinfeng Ning Manton Business and Technology Services (Shanghai) 37 Winding Ridge, Oakland, NJ 07436 USA Tel: 1-504-256-3616 Email: cyshen@aol.com
Secondary Contact Person Charles Shen Manton Business and Technology Services (Shanghai) 37 Winding Ridge, Oakland, NJ 07436, USA Tel: 1-608-217-9358 Email: cyshen@aol.com
5.3 Date of Summary: March 25, 2024
5.4 Device Name:
Proprietary Name:
- Common Name: Classification Name: Device Classification: Regulation Number: Panel: General Product Code:
Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro) Dental Zirconia Ceramics Powder, Porcelain II 21 CFR 872.6660 Dental EIH
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ર્સ રાજ્યના સાથે અને સાથે સાથે સાથે છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી Predicate Device Information:
K152175, "Dental Zirconia Blank for Aesthetic Restoration", manufactured by "Liaoning Upcera Co., Ltd."
ર્સ્વ Device Description:
"Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" is derived from zirconia powder that has been processed through various molding and sintering techniques – into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. The zirconia powder is composed of ZrO2 , Y2O3, HfO2 and other oxides. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.
"Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" is ceramic dental blanks designed for the manufacture of ceramic dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.
"Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" is supplied in different shapes, such as blocks, disc, and semi-disc, or customer ordered shapes. It is also supplied in the combinations of 21 different colors, and single and multi-layer aesthetic effect.
The different colors are originated from the different constituent of color additives (such as Fe>O3, Er>O3); and the multilayer aesthetic effect is originated from the different padding method used in the process of dry pressing.
5.7 Indications for Use:
"Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" is intended for use with CAD/CAM technology to produce all ceramic dental restorations as prescribed by a dentist. All blanks are processed through dental laboratories or by dental professionals.
5.8 Technological Comparison with Predicate Device
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
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| Description | Subject Device | Predicate Device (K152175) |
|---|---|---|
| Indication for | ||
| Use | “Dental Zirconia Block (Model: HT-plus, | |
| ST, SHT, UT, 3D-Pro)” is intended for | ||
| use with CAD/CAM technology to | ||
| produce all ceramic dental restorations as | ||
| prescribed by a dentist. All blanks are | ||
| processed through dental laboratories or | ||
| by dental professionals | Is mainly used in prosthetic treatment. | |
| While the flexural strength of Dental | ||
| Zirconia Ceramics after sintering is | ||
| between 300-500 MPa, the product can | ||
| be used for veneering, inlay, single | ||
| crown, and substructure ceramic for | ||
| three-unit prostheses not involving | ||
| molar restoration; While the flexural | ||
| strength of Dental Zirconia Ceramics | ||
| after sintering is over 500 MPa, it can | ||
| be used for veneering, inlay, single | ||
| crown, and substrate ceramic for three- | ||
| unit prostheses. | ||
| Basic Design | Blocks, disc, and semi-disc | Blocks, disc, and rod |
| Materials | Zirconia (ZrO2 + Y2O3 + HfO2 ≥ 98%) | |
| Inorganic pigments | Zirconia (ZrO2 + Y2O3 + HfO2 ≥ 98%) | |
| Inorganic pigments | ||
| Processing | Sintering at temperature > 1400 °C | Sintering at temperature > 1400 °C |
| Dimension | Various | Various |
| Single Use | Yes | Yes |
| Shade | Twenty one colors | Forty six colors |
| Aesthetic | ||
| Effect | Two aesthetic effects: single and | |
| multilayer effect | Two aesthetic effects: single and | |
| multilayer effect | ||
| Translucency | ||
| effect | Same translucency for all blocks | Three translucency effects. Each blank |
| has a single translucency effect. | ||
| Translucency is resulted from the | ||
| small variations in Y2O3 content | ||
| Sterile | Non-sterile | Non-sterile |
Table 5.1: Comparison of Intended Use, Design, Material, and Processing
Our device is essentially identical to the predicate device in terms of indications for use, design, material, and processing between our device and the predicate devices. The minor differences do not raise any safety and effectiveness concerns.
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રું છે.
વર્ષના વિ Summary of Non-Clinical Testing:
Bench testing was performed per ISO 6872:2008 and internal procedures to ensure that the "Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" met its specifications.
The following tests were performed: Uniformity Freedom from Extraneous Materials Radioactivity Shrinkage factor Sintered Density before Sintering Sintered Density after Sintering Expansion Coefficient Sintered Flexural Strength Chemical Solubility Vickers hardness
All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalence of the materials that are used.
Per FDA's guidance document entitled "Use of International Standard ISO 10993-1, `Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,"", as well as ISO 10993-1: 2018, the following biocompatibility endpoints are considered:
Cytotoxicity (ISO 10993-5) Irritation & Sensitization (ISO 10993-10) Acute Systematic Toxicity (ISO 10993-11) Subacute Subchronic Systematic Toxicity (ISO 10993-11) Material Mediated Pyrogenicity (ISO 10993-11) Implantation (ISO 10993-6) Chronic Systematic Toxicity (ISO 10993-11) Genotoxicity (ISO 10993-3) Carcinogenicity (ISO 10993-3)
Biocompatibility was evaluated per ISO 19993-1: 2009, and it was found that the subject device is as biocompatible as the predicate device.
5.10 Summary of Clinical Study:
Clinical Study is not performed for this device.
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5.11 Substantial Equivalence Conclusion
It has been shown in this 510(k) submission that "Dental Zirconia Block (Model: HTplus, ST, SHT, UT, 3D-Pro)" and its predicate devices have similar indications for use, similar composition, and biocompatibility, similar manufacturing process, and similar performance.
The difference between the "Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" and their predicate device do not raise any question regarding its equivalence.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, the subject device is respectively substantially equivalent to the predicate device.