Non-Sterile Zirconia Block (Model: Zircos-E ACE) is 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: Zircos-E ACE) is a manufacture unit that is cut, processed and sintered by CAD/CAM system of the computers designed for production of dental restoration.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called "Non-Sterile Zirconia Block (Model: Zircos-E ACE)". This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics, rather than a study proving the device meets specific acceptance criteria for diagnostic or clinical performance in the way an AI/software device would.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device are not applicable to this submission.

Here's a breakdown of the information available and why certain aspects are not present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison table (Table 1) between the subject device and the predicate device based on various technical characteristics. It asserts "Equivalence" for each characteristic, indicating that the subject device's performance is expected to be comparable and meet similar standards as the predicate. The "acceptance criteria" here are largely implied by the predicate characteristics and compliance with a standard (ISO 6872).

ITEM	Acceptance Criteria (Implied by Predicate/Standard)	Reported Device Performance (Subject Device)
Product Code	EIH	EIH
Regulation Number	872.6660	872.6660
Indication for use	Production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.	Production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Feature	Colored	Colored
Shape	Discs	Discs
Type and Class per ISO 6872:2015	Type II Class 5	Type II Class 5
Sterility	Non-sterile	Non-sterile
Chemical Composition	ZrO2 with others	ZrO2 with others
Crystal Morphology	Tetragonal	Tetragonal
Density	6.00g/cm³	6.00g/cm³
Sintering temperature	$1500\pm50°C$	$1500\pm50°C$
Performance	Comply with ISO 6872	Comply with ISO 6872 (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.)
Contact Level	Surface device with permanent contact	Surface device with permanent contact
Biocompatibility	Tested for Cytotoxicity, irritation, sensitization, acute systematic toxicity, genotoxicity, no adverse react	Tested for Cytotoxicity, irritation, sensitization, accurate systematic toxicity, genotoxicity, no adverse react. (Specifically: Cytotoxicity per ISO 10993-5:2009; Intracutaneous Reactivity Test per ISO 10993-10:2010; Sensitization Test per ISO 10993-10:2010; Acute Systematic Toxicity per ISO 10993-11:2006).

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

Sample Size: Not explicitly stated as a "test set" in the context of clinical or diagnostic performance. For the non-clinical tests (Density, Biocompatibility), the sample sizes used are standard for material testing, but not explicitly detailed in this summary.
Data Provenance: The tests are non-clinical, conducted according to ISO standards. The origin of the raw material data for these tests is internal to the manufacturer or their testing labs.

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

Not Applicable. This device is a material (zirconia block) for dental restorations, not a diagnostic or AI device that requires expert ground truth for its performance evaluation. The "ground truth" for material properties is established by physical and chemical testing against established standards.

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

Not Applicable. As above, this is for material testing, not a diagnostic study requiring adjudication of expert interpretations.

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. This is a material device, not an AI or software product.

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

Not Applicable. This is a material device, not an AI or software product.

7. The type of ground truth used:

For the performance characteristics, the "ground truth" is derived from international standard specifications (e.g., ISO 6872 for ceramic materials, ISO 10993 for biocompatibility) and direct quantitative measurements of the material's physical, chemical, and biological properties.

8. The sample size for the training set:

Not Applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not Applicable. As above.

Summary

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March 10, 2021

Bioden Co., Ltd % Chris Park General Manager Med.com 1809 Holland dr Somerset, New Jersey 08873

Re: K201492

Trade/Device Name: Non-Sterile Zirconia Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: December 3, 2020 Received: December 10, 2020

Dear Chris Park:

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 medical devices and radiation-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 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) K201492

Device Name Non-Sterile Zirconia Block Model: name: Zircos-E ACE

Indications for Use (Describe)

Non-Sterile Zirconia Block (Model: Zircos-E ACE) is 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

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92

The assigned 510(k) Number: K201492

1. Date of Preparation: Mar/09/2021
1. Sponsor Identification BIODEN Co.,Ltd Address: #B-803 119, Gasan digital 1-ro, Geumcheon-gu, Korea Establishment Registration Number: Not yet registered for the Number Contact Person: MyeongEun Song Position: QA Tel: +82-2-6292-2840 Fax: 82-2-6292-2846

Email: < bio0790@daum.net>

1. Identification of Proposed Device Trade Name: Non-Sterile Zirconia Block Common Name: Zirconia Blocks
  Regulatory Information Classification Name: Porcelain powder for clinical use Classification: 2 Product Code: EIH Regulation Number: 872.6660 Review Panel: Dental Indications for Use Statemen: Non-Sterile Zirconia Block (Model name: Zircos-E ACE) is 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: Zircos-E ACE) is a manufacture unit that is cut, processed and sintered by CAD/CAM system of the computers designed for production of dental restoration.

1. Identification of Predicate Device(s)
  Primary predicate
510(k) number: K190112
Company: FINE ADVANCED COMPOUND Co., Ltd
Model: Finebase, Montblanc, Trione HT, Trione C, Trione HT+
Classification: Class II

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Non-Clinical Test Conclusion ર.
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. >
Density Test
Cytotoxicity per ISO 10993-5:2009;
Intracutaneous Reactivity Test per ISO 10993-10:2010;
Sensitization Test per ISO 10993-10:2010
Acute Systematic Toxicity per ISO 10993-11:2006;
1. Clinical Test Conclusion

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Comparison

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510(k) Summary

Table 1 Comparison of Technology Characteristics
ITEM	Non-Sterile Zirconia Block(Model name: Zircos-E ACE)	Non-Sterile Zirconia Block(Model name: Finebase, Montblanc, Trione HT, Trione C, Trione HT+)	Model names various
Product Code	EIH	EIH	Equivalen
Regulation Number	872.6660	872.6660	Equivalence
Indication for use	Non-Sterile Zirconia Block(Model name: Zircos-E ACE) are indicated for theproduction of artificial teeth in fixed or removabledentures, or for jacket crowns, facings, and veneers.	Non-Sterile Zirconia Block(Model name: Finebase, Montblanc, Trione HT, Trione C, Trione HT+) are indicated for theproduction of artificial teeth in fixed or removable dentures,or for jacket crowns, facings, and veneers.	Indication for use is equal
Feature	Colored	Colored	Equivalencel
Shape	Discs	Discs	Equivalence
Type and Classper ISO 6872:2015	Type II Class 5	Type II Class 5	Equivalence
Sterility	Non-sterile	Non-sterile	Equivalence
ChemicalComposition	ZrO2 with others	ZrO2 with others	Equivalencel
CrystalMorphology	Tetragonal	Tetragonal	Equivalence
Density	6.00g/cm3	6.00g/cm3	Equivalence
Sinteringtemperature	$1500\pm50°C$	$1500\pm50°C$	Equivalence
Performance	Comply with ISO 6872	Comply with ISO 6872	Equivalence
Contact Level	surface device with permanentcontact	surface device with permanentcontact	Equivalence
Biocompatibility	Tested for Cytotoxicity,irritation, sensitization,accurate systematic toxicity,genotoxicity, no adverse react	Tested for Cytotoxicity,irritation, sensitization, accuratesystematic toxicity, genotoxicity,no adverse react	Equivalence

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Subject device, Based on the table above, the intended use of Zircos-E ACE is identical to the other equivalent devices and there is no significant clinical difference in the performance and stability when comparing the technical characteristics and biological natures.

Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices Non-Sterile Zirconia Block (Model name: Zircos-E ACE) is determined to be Substantially Equivalent (SE) to the predicate devices K190112/ Company: FINE ADVANCED COMPOUND Co., Ltd/ Model: Finebase, Montblanc, Trione HT, Trione C, Trione HT+.

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.