(129 days)
Not Found
No
The summary describes a material (zirconia block) used in a CAD/CAM system for dental restorations. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the material properties and biocompatibility.
No.
This device is a material (Zirconia Block) used to produce dental restorations, not a therapeutic device that directly treats a medical condition.
No
This device is a zirconia block used to produce dental restorations (artificial teeth, crowns, facings, veneers) and not for diagnosing any medical condition.
No
The device description clearly states it is a "Non-Sterile Zirconia Block," which is a physical material used to produce dental restorations. The performance studies also focus on material properties and biocompatibility, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the production of artificial teeth (fixed or removable dentures, jacket crowns, facings, and veneers). This is a manufacturing process for dental prosthetics.
- Device Description: The device is a block of material used in a CAD/CAM system to create dental restorations.
- Lack of Diagnostic Purpose: IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens for diagnostic purposes.
- Focus on Manufacturing: The description clearly focuses on the use of the zirconia block as a material for creating dental devices.
The information provided describes a material used in the manufacturing of dental prosthetics, which falls under the category of dental devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Non-Sterile Zirconia Block (Model name: ARENA Star, Mont Blanc) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Non-Sterile Zirconia Block (Model name: ARENA Star. MontBlanc), used to produce dental restoration to support designing computer for dental use and to process cutting as a manufacture unit, on which CAD/CAM system is applied for processing and sintering.
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
Not Found
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device, including
- Performance Test per ISO 6872 Fourth Edition 2015-06-01, Dentistry Ceramic Materials; .
- Cytotoxicity per ISO 10993-5:2009:
- Intracutaneous Reactivity Test per ISO 10993-10:2010;
- Sensitization Test per ISO 10993-10:2010;
- Acute Systemic Toxicity per ISO 10993-11:2017.
Biocompatibility evaluation of proposed Non-Sterile Zirconia Block was considered followed the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." the ISO 10993 suite of standards. The biocompatibility for the proposed device was found to be substantially equivalent to the predicate devices as a result.
Proposed Non-Sterile Zirconia Block has been designed and tested in accordance with ISO 6872 Dentistry - Ceramic Materials. All tests have passed the evaluation criteria and met the requirement of product-specific ISO 6872 specifies for Class 5 dental ceramics. The mechanical properties were found to be substantially equivalent to the predicate devices as a result.
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.
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February 27, 2023
Arumdentistry Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K223253
Trade/Device Name: Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: February 2, 2023 Received: February 2, 2023
Dear April Lee:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. 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
510(k) Number (if known) K223253
Device Name
Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)
Indications for Use (Describe)
Non-Sterile Zirconia Block (Model name: ARENA Star, Mont Blanc) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
Submitter
ARUMDENTISTRY Co., Ltd. Hyang Mi Lee 23, Gukjegwahak 11-Ro, Yuseong-gu, Daejeon, 34002, Republic of Korea Email: arum ra@arumdentistry.com Tel. +82-42-935-3644 Fax. +82-42-935-3633
Official Correspondent
Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
Device Information
- Trade Name: Non-Sterile Zirconia Block (ARENA Star, MontBlanc)
- . Common Name: Powder, Porcelain
- . Classification Name: Porcelain Powder For Clinical Use
- . Product Code: EIH
- Panel: Dental ●
- Regulation Number: 21 CFR 872.6660 ●
- . Device Class: Class II
- . Date Prepared: 02/24/2023
Predicate Device:
The subject device is substantially equivalent to the following predicate device:
- K190112, Non-Sterile Zirconia Block by FINE ADVANCED COMPOUND Co., Ltd. ●
Indication for Use:
Non-Sterile Zirconia Block (Model name: ARENA Star, MontBlanc) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Device Description:
Non-Sterile Zirconia Block (Model name: ARENA Star. MontBlanc), used to produce dental restoration to support designing computer for dental use and to process cutting as a manufacture unit, on which CAD/CAM system is applied for processing and sintering.
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| Subject Device | Primary Predicate | SE | |
|---|---|---|---|
| 510(k) Number | K223253 | K190112 | |
| Company | ARUMDENTISTRY Co., Ltd. | FINE ADVANCED COMPOUND | |
| Co., Ltd. | |||
| Device Name | Non-Sterile Zirconia Block | Non-Sterile Zirconia Block | |
| Model Name | ARENA Star, MontBlanc | Finebase, Montblanc, Trione HT, | |
| Trione C, Trione HT+ | |||
| Device | |||
| Classification | POWDER, PORCELAIN/ | ||
| Porcelain Powder For Clinical Use | POWDER, PORCELAIN/ | ||
| Porcelain Powder For Clinical Use | Same | ||
| Product Code | EIH | EIH | Same |
| Regulation | |||
| Number | 21 CFR 872.6660 | 21 CFR 872.6660 | Same |
| Indications for | |||
| Use | Non-Sterile Zirconia Block (Model | ||
| name: ARENA Star, MontBlanc) | |||
| are indicated for the production of | |||
| artificial teeth in fixed or removable | |||
| dentures, or for jacket crowns, | |||
| facings, and veneers. | Non-Sterile Zirconia Block (Model | ||
| name: Finebase, Montblanc, Trione | |||
| HT, Trione C, Trione HT+) are | |||
| indicated for the production of | |||
| artificial teeth in fixed or removable | |||
| dentures, or for jacket crowns, | |||
| facings, and veneers. | Same | ||
| Principle of | |||
| Operations | This partial sintered zirconia block | ||
| is milled and finally sintered to | |||
| make dental prosthesis | This partial sintered zirconia block | ||
| is milled and finally sintered to | |||
| make dental prosthesis | Same | ||
| Feature | Colored | Colored | Same |
| Shape | Discs | Discs | Same |
| Classification | Type II Class 5 | Type II Class 5 | Same |
| Standard | |||
| Conformed | ISO 6872:2015 | ISO 6872:2015 | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Chemical | |||
| Composition | ZrO2 with others | ZrO2 with others | Same |
| Crystal | |||
| Morphology | Tetragonal | Tetragonal | Same |
| Flexural | |||
| Strength | 800Mpa | 800 MPa | Same |
| Sintering | |||
| temperature | $1500 \pm 50$ °C | $1500 \pm 50$ °C | Same |
| Contact Level | Surface device with permanent | ||
| contact | Surface device with permanent | ||
| contact | Same | ||
| Biocompatibility | Tested for Cytotoxicity, irritation, | ||
| sensitization, acute systemic | |||
| toxicity, no adverse reaction. | Tested for Cytotoxicity, irritation, | ||
| sensitization, acute systemic | |||
| toxicity, no adverse reaction. | Same | ||
| Similarities | The subject device and the primary predicate have similar indications, principle of operation, | ||
| technological characteristics, and materials. They encompass the same range of physical and | |||
| chemical properties. Therefore, both devices are substantial equivalent. | |||
| Differences | The differences between the subject device and predicate are material supplier and addition of | ||
| shades. The chemical composition of both devices are same but the material suppliers are | |||
| different. Therefore, both devices are substantial equivalent. |
Summaries of Technological Characteristics & Substantial Equivalence Discussion
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Non-Clinical Test Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device, including
- Performance Test per ISO 6872 Fourth Edition 2015-06-01, Dentistry Ceramic Materials; .
- . Cytotoxicity per ISO 10993-5:2009:
- . Intracutaneous Reactivity Test per ISO 10993-10:2010;
- . Sensitization Test per ISO 10993-10:2010;
- . Acute Systemic Toxicity per ISO 10993-11:2017.
Biocompatibility Evaluation
Biocompatibility evaluation of proposed Non-Sterile Zirconia Block was considered followed the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." the ISO 10993 suite of standards. The biocompatibility for the proposed device was found to be substantially equivalent to the predicate devices as a result.
Sterilization Validation and Shelf-life
Proposed Non-Sterile Zirconia Block is delivered in non-sterile status and this device is unnecessary of sterilization prior to use. Therefore, sterilization was not considered.
Mechanical Properties
Proposed Non-Sterile Zirconia Block has been designed and tested in accordance with ISO 6872 Dentistry - Ceramic Materials. All tests have passed the evaluation criteria and met the requirement of product-specific ISO 6872 specifies for Class 5 dental ceramics. The mechanical properties were found to be substantially equivalent to the predicate devices as a result.
Clinical Test Conclusion
No clinical study is included in this submission.
Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be substantially equivalent to the predicate device.