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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding a dental device, specifically "Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)". It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria through clinical or even extensive non-clinical performance data against set thresholds.

Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment (typical for AI/software as a medical device submissions) are not present in this document. This submission primarily relies on showing similarity in material properties and intended use to an already cleared device.

Here's an attempt to answer your questions based solely on the provided text:

Device: Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)

1. Table of acceptance criteria and the reported device performance

The document does not present a table of acceptance criteria with specific quantitative thresholds that the device was tested against in a performance study, nor does it report detailed device performance metrics beyond stating that tests "passed the evaluation criteria and met the requirement."

Instead, it relies on comparison to a predicate device and adherence to a recognized standard (ISO 6872:2015). The "acceptance criteria" are implied by meeting the requirements of this standard and demonstrating equivalence to the predicate.

Characteristic	Acceptance Criterion (Implied by ISO 6872:2015 & Predicate Equivalence)	Reported Device Performance
Flexural Strength	800 MPa (matching predicate and ISO standard requirements)	800Mpa
Sintering Temperature	$1500 \pm 50$ °C (matching predicate)	$1500 \pm 50$ °C
Biocompatibility	No adverse reaction (Cytotoxicity, irritation, sensitization, acute systemic toxicity)	Tested for Cytotoxicity, irritation, sensitization, acute systemic toxicity, no adverse reaction.
Mechanical Properties	Met requirements of ISO 6872 Class 5 for dental ceramics	All tests have passed the evaluation criteria and met the requirement of product-specific ISO 6872 specifies for Class 5 dental ceramics.

Note: The document explicitly states "No clinical study is included in this submission." The reported performance is based on non-clinical, in-vitro testing.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes (e.g., number of blocks, number of samples tested for biocompatibility, etc.) used for the non-clinical tests.

The data provenance is from non-clinical tests conducted by ARUMDENTISTRY Co., Ltd. (Republic of Korea, based on the submitter's address). The tests are in-vitro studies, not clinical data from patients. The document does not specify if the data is retrospective or prospective, but given it's non-clinical testing, it would generally be considered prospective for the purpose of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this submission. The "ground truth" for material properties is established through standardized laboratory testing methods (e.g., measuring flexural strength, chemical composition, biocompatibility assays), not through expert consensus or interpretation of medical images. No human readers or experts are mentioned in the context of "ground truth" for the performance tests conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation (e.g., radiology reads) to establish a consensus ground truth. The tests performed are objective, laboratory measurements of material properties, not subjective assessments requiring adjudication.

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 question is not applicable. This device is a dental material (zirconia block) used for manufacturing dental prosthetics, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and assessment of AI assistance for human readers are not relevant. The document explicitly states, "No clinical study is included in this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This device is a physical dental material, not an algorithm or software. Therefore, "standalone algorithm-only performance" is not a concept that applies here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests is based on objective, quantitative measurements of material properties according to recognized international standards (e.g., ISO 6872:2015 for mechanical properties, ISO 10993 series for biocompatibility). For instance, flexural strength is measured directly, rather than being determined by expert consensus or pathology.

8. The sample size for the training set

This question is not applicable. This is a physical device submission demonstrating substantial equivalence to a predicate, not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable, as there is no training set for this type of device submission.

Summary

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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

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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:

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	Subject Device	Primary Predicate	SE
510(k) Number	K223253	K190112
Company	ARUMDENTISTRY Co., Ltd.	FINE ADVANCED COMPOUNDCo., Ltd.
Device Name	Non-Sterile Zirconia Block	Non-Sterile Zirconia Block
Model Name	ARENA Star, MontBlanc	Finebase, Montblanc, Trione HT,Trione C, Trione HT+
DeviceClassification	POWDER, PORCELAIN/Porcelain Powder For Clinical Use	POWDER, PORCELAIN/Porcelain Powder For Clinical Use	Same
Product Code	EIH	EIH	Same
RegulationNumber	21 CFR 872.6660	21 CFR 872.6660	Same
Indications forUse	Non-Sterile Zirconia Block (Modelname: ARENA Star, MontBlanc)are indicated for the production ofartificial teeth in fixed or removabledentures, or for jacket crowns,facings, and veneers.	Non-Sterile Zirconia Block (Modelname: Finebase, Montblanc, TrioneHT, Trione C, Trione HT+) areindicated for the production ofartificial teeth in fixed or removabledentures, or for jacket crowns,facings, and veneers.	Same
Principle ofOperations	This partial sintered zirconia blockis milled and finally sintered tomake dental prosthesis	This partial sintered zirconia blockis milled and finally sintered tomake dental prosthesis	Same
Feature	Colored	Colored	Same
Shape	Discs	Discs	Same
Classification	Type II Class 5	Type II Class 5	Same
StandardConformed	ISO 6872:2015	ISO 6872:2015	Same
Sterility	Non-sterile	Non-sterile	Same
ChemicalComposition	ZrO2 with others	ZrO2 with others	Same
CrystalMorphology	Tetragonal	Tetragonal	Same
FlexuralStrength	800Mpa	800 MPa	Same
Sinteringtemperature	$1500 \pm 50$ °C	$1500 \pm 50$ °C	Same
Contact Level	Surface device with permanentcontact	Surface device with permanentcontact	Same
Biocompatibility	Tested for Cytotoxicity, irritation,sensitization, acute systemictoxicity, no adverse reaction.	Tested for Cytotoxicity, irritation,sensitization, acute systemictoxicity, 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 andchemical properties. Therefore, both devices are substantial equivalent.
Differences	The differences between the subject device and predicate are material supplier and addition ofshades. The chemical composition of both devices are same but the material suppliers aredifferent. 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.

Regulation Number and Section

§ 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.