Estar-Z is prefabricated ceramic block (pre-sintered yttrium-stabilized zirconium oxide) which is to be milled and sintered in the furnace to produce the final dental restorations. After sintering, it forms polycrytstalline oxide ceramic consisted of Tetragonal Zirconium Oxide Polycrystal (TZP).

Estar-Z is provided in three types as Estar-Z T, Estar-Z HT, and Estar-Z ST. In accordance with ISO 6872:2015, Estar-Z T and Estar-Z HT are classified as Type II Class 5 zirconia and Estar-Z ST is classified as Type II Class 4b zirconia.

Estar-Z is provided in non-sterile and available in various shades and thickness of disk shape (Ø98mm).

AI/ML Overview

The provided document is a 510(k) Summary for the dental ceramic device Estar-Z. It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. As such, it does not contain information about a study proving the device meets specific acceptance criteria using a human-in-the-loop or standalone AI performance evaluation. This document details the physical properties and biocompatibility of the ceramic material itself.

Therefore, many of the requested elements for an AI device study (e.g., sample sizes of test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this document.

However, I can extract the acceptance criteria and reported device performance for the physical properties of the ceramic material, as this is the focus of the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by the ISO 6872:2015 standard for dentistry ceramic materials. The reported device performance is compared against these standards and the predicate devices.

Property	Standard/Acceptance Criteria (ISO 6872:2015)	Estar-Z T & HT (reported)	Estar-Z ST (reported)	Predicate Device LUXEN Zr (K171585 - reported)	Predicate Device LUXEN Smile (K171585 - reported)
Classification	Type II Class 5 (for Estar-Z T & HT)	Met	N/A	Type II Class 5	N/A
Flexural Strength	>800 MPa (for Type II Class 5)	>800 MPa	N/A	1038 ± 135 MPa (for Type II Class 5)	N/A
Classification	Type II Class 4b (for Estar-Z ST)	N/A	Met	N/A	Type II Class 4b
Flexural Strength	>500 MPa (for Type II Class 4b)	N/A	>500 MPa	N/A	770 ± 66 MPa (for Type II Class 4b)

2. Sample size used for the test set and the data provenance
This information is not provided in the document. The document refers to non-clinical testing with "evaluation criteria" from ISO standards but does not specify sample sizes for these tests. Data provenance (country of origin, retrospective/prospective) is not applicable to material properties testing described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in this context refers to physical material properties measured according to established ISO standards, not expert interpretations of medical images or clinical data.

4. Adjudication method for the test set
Not applicable.

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
Not applicable, as this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI device.

7. The type of ground truth used
The ground truth used for performance evaluation of Estar-Z's physical properties are the specifications and requirements set forth by international standards, specifically ISO 6872:2015 for Dentistry Ceramic Materials and ISO 13356:2015 for Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

For biocompatibility, the ground truth is established by adherence to ISO 10993 series and ISO 7405 standards.

8. The sample size for the training set
Not applicable, as this is not an AI device that requires a training set.

9. How the ground truth for the training set was established
Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

July 2, 2021

Osstem Implant Co., Ltd. % Peter Lee RA/QA Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030

Re: K210097

Trade/Device Name: Estar-Z Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: June 3, 2021 Received: June 4, 2021

Dear Peter 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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, 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) K210097

Device Name Estar-Z

Indications for Use (Describe)

Estar-Z is a ceramic intended to manufacture dental restorations, including inlays, artificial teeth, crowns and bridges.

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)

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STEM
PLANT
A-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, Korea
Tel: +82 70 4394 7896 Fax: +82 31 498 0824 www.osstem.com

510(k) Summary

K210097

Date: June 03, 2021

1. Company and Correspondent making the submission

- Submitter's Name	: Osstem Implant Co., Ltd.
- Address	: A-dong, 51, Mayu-ro 238beon-gil, Siheung-SiGyeonggi-do, 15079, Republic of Korea
- Contact	: Ms. Jungmin Yoo
- Phone	: +82-70-4394-7896
- Correspondent's Name	: Hiossen Inc.
- Address	: 85 Ben Fairless Dr. Fairless Hills, PA 19030
- Contact	: Mr. Peter Lee
- Phone	: +1-267-759-7031

2. Proposed Device

- Trade or (Proprietary) Name	: Estar-Z
- Classification Name	: Porcelain powder for clinical use
- Regulation Number	: 21 CFR 872.6660
- Devce Classification	: Class II
- Classification Product Code	: EIH

3. Predicated Device(s)

Primary Predicate -LUXEN Zr, LUXEN Smile, DENTALMAX Co., Ltd. (K171785)

4. Description

Estar-Z is a ceramic intended to manufacture dental restorations, including inlays, artificial teeth, crowns and bridges.

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Image /page/4/Picture/0 description: The image shows the logo and contact information for Osstem Implant Co., Ltd. The logo includes the company name and the word "IMPLANT" in smaller letters. The contact information includes the company's address, phone number (+82 70 4394 7896), fax number (+82 31 498 0824), and website (www.osstem.com).

Estar-Z is provided in non-sterile and available in various shades and thickness of disk shape (Ø98mm) as follows:

Estar-Z T
Shade	A0, A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, D2, D3, D4
Thickness (mm)	10, 12, 14, 16, 18, 20, 22, 25

Estar-Z HT
Shade	A0, A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, Z4Multi A1, Multi A2, Multi A3, Multi A3.5, Multi A4, Multi B1, Multi B2,Multi B3, Multi B4, Multi C1, Multi C2, Multi C3, Multi C4, Multi D2, Multi D3, Multi D4
*Shade with 'Multi': Multi-layered zirconia has color gradation similar to the color of natural teeth.
Thickness (mm)	10, 12, 14, 16, 18, 20, 22, 25

Estar-Z ST
Shade	A0, A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, D2, D3, D4
Thickness (mm)	10, 12, 14, 16, 18, 20, 22, 25

5. Substantial Equivalent Comparison

	Proposed Device	Predicate Device	Comparison
Device Name	Estar-Z TEstar-Z HT	LUXEN Zr	Different
510(k) Number	K210097	K171585	Different
Manufacturer	Osstem Implant Co., Ltd.	DENTALMAX Co., Ltd.	Different
Regulation Name	Porcelain powder for clinical use	Porcelain powder for clinical use	Same
Regulation Number	872.6660	872.6660	Same
Product Code	EIH	EIH	Same
Device Class	II	II	Same
Indications for Use	Estar-Z is a ceramic intended tomanufacture dental restorations,including inlays, artificial teeth,crowns and bridges.	LUXEN Zr is indicated for theproduction of all-ceramic inlays,multi-units bridges, onlays, andveneers without zirconium dioxideframeworks.	Similar
Principle ofOperations	This partial sintered zirconia block ismilled and finally sintered to makedental prosthesis.	This partial sintered zirconia block ismilled and finally sintered to makedental prosthesis.	Same

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Image /page/5/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. To the right of the word "OSSTEM" is a small, raised circle, which is a trademark symbol.

Osstem Implant Co., Ltd.

A-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, Korea
Tel: +82 70 4394 7896 Fax: +82 31 498 0824 www.osstem.com

P

Physical Properties
StandardConformed	ISO 6872:2015	ISO 6872:2015	Same
Classification	Type II Class 5	Type II Class 5	Same
FlexuralStrength	$>800 MPa$	$1038 ± 135 MPa$	Similar
DeliveryForm(s)	Disk type	Disk type	Same
Thickness	10, 12, 14, 16, 18, 20, 22, 25mm	10, 12, 14, 16, 18, 20, 22, 25mm	Same
Shade(s)	Estar-Z T:A0, A1, A2, A3, A3.5, A4,B1, B2, B3, B4,C1, C2, D2, D3, D4Estar-Z HT:A0, A1, A2, A3, A3.5, A4,B1, B2, B3, B4,C1, C2, C3, C4,D2, D3, D4, Z4,Multi A1, Multi A2, Multi A3, MultiA3.5, Multi A4, Multi B1, Multi B2,Multi B3, Multi B4,Multi C1, Multi C2, Multi C3, MultiC4, Multi D2, Multi D3, Multi D4	A0, A1, A2, A3,B1, B2, B3, B4, C4,B1-B2-B3-B4LAYER	Different
Sterile	Non-sterile	Non-sterile	Same
Biocompatibility Evaluation
StandardConformed	ISO 10993-1 and ISO 7405	ISO 10993-1	Similar
Classification	Externally communicating device inoral mucosa, enamel, and dentin;	Externally communicating device inoral mucosa, enamel, and dentin;	Same

	Proposed Device	Predicate Device	Comparison
Device Name	Estar-Z ST	LUXEN Smile	Different
510(k) Number	K210097	K171585	Different
Manufacturer	Osstem Implant Co., Ltd.	DENTALMAX Co., Ltd.	Different
Regulation Name	Porcelain powder for clinical use	Porcelain powder for clinical use	Same
Regulation Number	872.6660	872.6660	Same
Product Code	EIH	EIH	Same
Device Class	II	II	Same
Indications for Use	Estar-Z is a ceramic intended tomanufacture dental restorations,including inlays, artificial teeth,crowns and bridges.	LUXEN Zr is indicated for theproduction of all-ceramic inlays,multi-units bridges, onlays, andveneers without zirconium dioxideframeworks.	Similar

(>30d)

and contact duration of C-long term

(>30d)

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Image /page/6/Picture/0 description: The image contains the logo for Osstem Implant. The logo is in orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, thinner font. There is a degree symbol to the right of the word "OSSTEM".

Osstem Implant Co., Ltd.

A-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, Korea
Tel: +82 70 4394 7896 Fax: +82 31 498 0824 www.osstem.com

Principle ofOperations	This partial sintered zirconia block ismilled and finally sintered to makedental prosthesis.	This partial sintered zirconia block ismilled and finally sintered to makedental prosthesis.	Same
Physical Properties
StandardConformed	ISO 6872:2015	ISO 6872:2015	Same
Classification	Type II Class 4b	Type II Class 4b	Same
FlexuralStrength	$>500$ MPa	$770 \pm 66$ MPa	Similar
DeliveryForm(s)	Disk type	Disk type	Same
Thickness	10, 12, 14, 16, 18, 20, 22, 25mm	10, 12, 14, 16, 18, 20, 22, 25mm	Same
Shade(s)	A0, A1, A2, A3, A3.5, A4,B1, B2, B3, B4,C1, C2, D2, D3, D4	A0, A1, A2, A3,B1, B2, B3, B4, C4,A1-A2-B3-B4 LAYERB1-B2-B3-B4 LAYER	Different
Sterile	Non-sterile	Non-sterile	Same
Biocompatibility Evaluation
StandardConformed	ISO 10993-1 and ISO 7405	ISO 10993-1	Similar
Classification	Externally communicating device inoral mucosa, enamel, and dentin;and contact duration of C-long term(>30d)	Externally communicating device inoral mucosa, enamel, and dentin;and contact duration of C-long term(>30d)	Same

6. Indications for Use

Estar-Z is a ceramic intended to manufacture dental restorations, including inlays, artificial teeth, crowns and bridges.

1. Summary of Non-clinical Performance Testing
  Non-clinical testing data are submitted to demonstrate substantial equivalence following FDA recognized standards:
ISO 6872:2015, Dentistry Ceramic materials .
. ISO 7405:2018, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
. ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
. ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
. ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

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Image /page/7/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, thinner font. To the right of the word "OSSTEM" is a small circle with a dot in the center, which is likely a registered trademark symbol.

Osstem Implant Co., Ltd.

A-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, Korea
Tel: +82.70 4394 7896 Fax: +82 31 498.0824 www.osstem.com

ISO 10993-14:2001, Biological evaluation of medical devices Part 14: Identification and qualification of degradation products from ceramics
. ISO 13356:2015, Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP)
ISO 14971:2007, Medical devices - Application of risk management to medical devices

Biocompatibility Evaluation

Biocompatibility evaluation of proposed Estar- Z 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," ISO 7405 and 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 Estar-Z is delivered in non-sterile status and this device is unnecessary of sterilization prior to use. Therefore, sterilization was not considered.

Mechanical Properties

Proposed Estar-Z has been designed and tested in accordance with ISO 6872 Dentistry - Ceramic Materials and ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). All tests have passed the evaluation criteria and met the requirement of product-specific ISO 6872 specifies for Class 4b and Class 5 dental ceramics. The mechanical properties were found to be substantially equivalent to the predicate devices as a result.

8. Summary of Clinical Testing

No clinical studies are submitted.

9. Conclusion

The conclusions drawn from the nonclinical and clinical tests that demonstrate that Estar-Z is as safe, as effective, and performs as well as the legally marketed 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.