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

K223253 · Arum Dentistry Co., Ltd. · EIH · Feb 27, 2023 · Dental

Device Facts

• Record ID: K223253
• Device Name: Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)
• Applicant: Arum Dentistry Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Feb 27, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended 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.

Device Story

Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) consists of partially sintered zirconia discs; used as raw material for dental restorations. Device processed by dental technicians using CAD/CAM systems; milling followed by sintering at 1500 ± 50 °C to achieve final dental prosthesis. Used in dental laboratories to create crowns, veneers, and dentures. Provides durable, biocompatible ceramic restorations for patients. No clinical data; performance verified via bench testing.

Clinical Evidence

No clinical data included. Bench testing only. Performance verified per ISO 6872:2015 (Dentistry Ceramic Materials). Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (intracutaneous reactivity and sensitization), and ISO 10993-11 (acute systemic toxicity).

Technological Characteristics

Material: Zirconia (ZrO2); Crystal morphology: Tetragonal; Form factor: Discs; Flexural strength: 800 MPa; Sintering temperature: 1500 ± 50 °C; Standards: ISO 6872:2015 (Type II Class 5); Sterilization: Non-sterile; Connectivity: None (mechanical raw material).

Indications for Use

Indicated for patients requiring artificial teeth, jacket crowns, facings, or veneers via fixed or removable dentures.

Regulatory Classification

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.

Predicate Devices

• Non-Sterile Zirconia Block (K190112)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 [e-mail] Tel. [phone] Fax. [phone]

## Official Correspondent

Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: [e-mail] Phone: [phone] Fax: [phone]

#### 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<br>Co., Ltd. | |
| Device Name | Non-Sterile Zirconia Block | Non-Sterile Zirconia Block | |
| Model Name | ARENA Star, MontBlanc | Finebase, Montblanc, Trione HT,<br>Trione C, Trione HT+ | |
| Device<br>Classification | POWDER, PORCELAIN/<br>Porcelain Powder For Clinical Use | POWDER, PORCELAIN/<br>Porcelain Powder For Clinical Use | Same |
| Product Code | EIH | EIH | Same |
| Regulation<br>Number | 21 CFR 872.6660 | 21 CFR 872.6660 | Same |
| Indications for<br>Use | Non-Sterile Zirconia Block (Model<br>name: ARENA Star, MontBlanc)<br>are indicated for the production of<br>artificial teeth in fixed or removable<br>dentures, or for jacket crowns,<br>facings, and veneers. | Non-Sterile Zirconia Block (Model<br>name: Finebase, Montblanc, Trione<br>HT, Trione C, Trione HT+) are<br>indicated for the production of<br>artificial teeth in fixed or removable<br>dentures, or for jacket crowns,<br>facings, and veneers. | Same |
| Principle of<br>Operations | This partial sintered zirconia block<br>is milled and finally sintered to<br>make dental prosthesis | This partial sintered zirconia block<br>is milled and finally sintered to<br>make dental prosthesis | Same |
| Feature | Colored | Colored | Same |
| Shape | Discs | Discs | Same |
| Classification | Type II Class 5 | Type II Class 5 | Same |
| Standard<br>Conformed | ISO 6872:2015 | ISO 6872:2015 | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Chemical<br>Composition | ZrO2 with others | ZrO2 with others | Same |
| Crystal<br>Morphology | Tetragonal | Tetragonal | Same |
| Flexural<br>Strength | 800Mpa | 800 MPa | Same |
| Sintering<br>temperature | $1500 \pm 50$ °C | $1500 \pm 50$ °C | Same |
| Contact Level | Surface device with permanent<br>contact | Surface device with permanent<br>contact | Same |
| Biocompatibility | Tested for Cytotoxicity, irritation,<br>sensitization, acute systemic<br>toxicity, no adverse reaction. | Tested for Cytotoxicity, irritation,<br>sensitization, acute systemic<br>toxicity, no adverse reaction. | Same |
| Similarities | The subject device and the primary predicate have similar indications, principle of operation,<br>technological characteristics, and materials. They encompass the same range of physical and<br>chemical properties. Therefore, both devices are substantial equivalent. | | |
| Differences | The differences between the subject device and predicate are material supplier and addition of<br>shades. The chemical composition of both devices are same but the material suppliers are<br>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.