INNI-CERA is intended for use in fabricating custom-made ceramic restorations using a 3D printer additive manufacturing process. It is a product that is used after fabricating and sintering with a mixture of zirconia powder and binder. The DLP 3D printer used to fabricate the INNICERA is a photocuring lamination method using an STL file (dental restoration shape), which is irradiated with light in the strong UV region (420nm) to cure the photocurable mixture to form a model. This product corresponds to ISO 6872 Type I Class III. The material is used in a 3D printer, which prints the shape determined by an STL file converted from patients' teeth data. 3D printer is not included with the product. INNI-CERA cannot be reused.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental material, INNI-CERA. The submission focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against acceptance criteria in a typical clinical study with human readers or AI.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable in this context. The document primarily describes bench testing to ensure the material meets established standards for dental ceramics.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (ISO 6872 requirements)	Reported Device Performance (INNI-CERA)
Flexural Strength	>300 MPa	>300 MPa
Chemical Solubility	< 100 µg/cm²	< 100 µg/cm²
Radioactivity	Activity concentration of uranium238 < 1.0 Bq g⁻¹	Activity concentration of uranium238 < 1.0 Bq g⁻¹
Biocompatibility	Meets EN ISO 10993-1 requirements	Met requirements (verified by various tests listed)
Shelf Life	Meets ISO 6872:2015 after accelerated aging	3 months (confirmed by accelerated aging test)

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The tests are bench tests on the material itself, not on patient data or a test set in the traditional sense of diagnostic AI.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth for material properties is established through standardized laboratory testing protocols (e.g., ISO 6872), not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. See explanation for point 3.

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 for dental restorations, not a diagnostic AI device requiring human reader studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a material for dental restorations, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for evaluating INNI-CERA's performance is based on established international standards for dental ceramic materials (ISO 6872:2015) and biocompatibility standards (ISO 10993-1). This involves objective measurements of material properties in a laboratory setting.

8. The Sample Size for the Training Set

Not applicable. INNI-CERA is a material, not a machine learning model, so there is no training set in the context of AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See explanation for point 8.

Summary

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Image /page/0/Picture/0 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 4, 2021

Aon Co., Ltd Sanghwa Myung Regulatory Affair Consultant E&m D-1474, 230, Simin-daero, Dongan-gu Anyang, Gyeonggi-do 14067 SOUTH KOREA

Re: K211308

Trade/Device Name: Inni-cera Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: August 4, 2021 Received: August 6, 2021

Dear Sanghwa Myung:

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, 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)

K211308

Device Name INNI-CERA

Indications for Use (Describe)

INNI-CERA is indicated for use by dental technicians in the construction of custom made all ceramic restorations.

Coping Crown Inlay & Onlay Veneer Bridge(3-unit anterior bridges)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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AON Co., Ltd

510(k) Summary

K211308

Aon Co., Ltd Submitter: A-Dong 2508,2201, 17, Gosan-ro 148beon-gil, Gunposi, Gyeonggi-do, 15850, South Korea Telephone: +82-31-689-5012 Fax: +82-31-689-5019 E-mail: jinhd0411@aoninni.com

Contact Person: Requlatory Affair/Sang Hwa Myung Telephone: +82-70-7807-0550 FAX: +82-31-388-9263 E-mail: mshenmc@gmail.com

Date 510(k) summary prepared: August 4th , 2021

Trade Name: INNI-CERA (BCM-W500, BCM-W1000)

Common Name: Dental Zirconia Material Regulation Name: Porcelain Powder for Clinical Use Classification: Class II Product Code: EIH Classification Panel: Dental Regulation Numbers: 21 CFR 872.6660 Type of 510(k) submission: Traditional

Description of Device:

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Indication for use:

INNI-CERA is indicated for use by dental technicians in the construction of custom-made ceramic restorations. Coping Crown Inlay & Onlay Veneer Bridge (3-unit anterior bridges)

Predicate Device:

Manufacturer: Ivoclar Vivadent, Incorporated

510(k) Number: K051705 Trade Name: IPS e.max ZirCAD Regulation Name: Porcelain Powder for Clinical Use Regulation Numbers: 21 CFR 872.6660 Product Code: EIH Classification: Class II

Substantial Equivalence:

Comparison table is as follows.

Table 1: Substantial equivalence comparison

Contents	Subject Device	Predicate Device
Manufacturer	Aon Co., Ltd	Ivoclar Vivadent, Incorporated
510(k)Number	Pending	K051705
Trade Name	INNI-CERA	IPS e.max ZirCAD
Indication for Use	INNI-CERA is indicatedfor use by dentaltechnicians in theconstruction of custommade all ceramicrestorations.CrownInlay & OnlayVeneerBridge(3-unit anteriorbridges)	IPS e.max ZirCADconsists of machinablezirconia blocks for thepreparation of fullceramic crowns, onlaysand 3- and 4-unit bridgesand inlay bridges(anterior andmolar.)
Material	Zirconia	Zirconia
Material Type	Slurry	Block
Biocompatibility	According to EN ISO10993-1	According to EN ISO10993-1
Flexural Strength	>300 MPa(meeting ISO 6872requirements)	>300 MPa(meeting ISO 6872requirements)
Chemical Solubility	< 100µg/cm²(meeting ISO 6872requirements)	< 100µg/cm²(meeting ISO 6872requirements)
Radioactivity	Activityconcentration ofuranium238 lessthan 1.0Bq g-1	Activityconcentration ofuranium238 lessthan 1.0Bq g-1

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	(meeting ISO 6872requirements)	(meeting ISO 6872requirements)
Sintering	YES	YES
Single Use	YES	YES
Non-sterile	YES	YES

Discussion

The information provided in this subject device is equivalence of indication for use, material, biocompatibility, Flexural Strength, Chemical Solubility, Radioactivity with the predicate device (K051705). The minor difference is that INNI-CERA's material type is slurry and K051705 is a block type. It is a biocompatible material according to ISO 10993-1. Therefore, the difference in material types will not raise concern about safety and effectiveness.

2) Reference Device

Manufacturer: Enlighten Materials Co., Ltd 510(k) Number: K191590 Trade Name: AA temp temporary restoration 3D printing photoreactive resin Regulation Name: Temporary crown and bridge resin Regulation Numbers: 872.3770 Product Code: EBG Classification: Class II

Contents	Subject Device	Reference Device	ComparisonComment
Manufacturer	Aon Co., Ltd	EnlightenMaterials Co., Ltd	-
510(k)Number	Pending	K191590	-
Trade Name	INNI-CERA	AA temptemporaryrestoration 3Dprintingphotoreactive resin	-
Indication for Use	INNI-CERA isindicated for useby dentaltechnicians in theconstruction ofcustom made allceramicrestorations.CrownInlay & OnlayVeneerBridge(3-unitanterior bridges)	AA temptemporaryrestoration 3Dprintingphotoreactive resinis a light-curablepolymerizableresin tofabricate, byadditivemanufacturing,temporarycrowns or bridges.	The manufacturingof restorationsusing a 3D printeris the same, thematerials aredifferent, but theuse of dentalmaterials for teethis the same.
Biocompatibility	According to ENISO 10993-1	According to ENISO 10993-1	SubstantialEquivalent
Production type	3D printing	3D printing	SubstantialEquivalent
Non-sterile	YES	YES	SubstantialEquivalent

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Discussion

A reference device is a dental manufactured by a 3d printer. K191590 is resin material but INNI-CERA is Zirconia material and It is a different material, but it is a biocompatible material according to ISO 10993-1. Both products manufacture dental restorations using 3D printer additive manufacturing. K191590 and subject device are used in a similar anatomical location for a similar physiological purpose. Therefore, the difference material will not raise concern of the safety and effectiveness.

Biocompatibility testing:

INNI-CERA dental zirconia materials were evaluated according to ISO 10993-1. The results of this test confirmed that it met the biocompatibility requirements. Biocompatibility testing. including cytotoxicity, sensitization, oral mucosal irritation, Acute Systemic Toxicity, Pyrogen Test, Subchronic systemic toxicity, Mammalian Erythrocyte Micronucleus Test (Carcinogenicity), AMES Test (Genotoxicity) was completed according to the following standards: ISO 10993-1 Biological Evaluation of Medical Devices –Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process ISO 10993-5 Biological Evaluation of Medical Devices - Part 5 Cytotoxicity ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization ISO 10993-12 Biological evaluation of medical devices-- ISO 10993-3: Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity, and reproductive and developmental toxicity, ISO 10993-11: Biological evaluation of medical devices -. Part 11: Tests for systemic.

Non-clinical Performance Data:

Bench Test:

The Predicate device of IPS e.max ZirCAD (K051705) meets the requirements of the applicable class, as detailed in the table under Technological characteristics. The performance of INN-CERA meets the requirements of non-clinical bench testing was conducted to support substantial equivalence.

Shelf life testing, INNI-CERA has shelf life of 3 month. The shelf testing has been through accelerated aging test and confirm the performance accordance with ISO 6872:2015

Risk Management

A risk analysis was conducted based on ISO 14971:2012 Medical devices – Application of risk management to medical devices

. Clinical Data:

No clinical performance testing was performed.

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Conclusion

In accordance with ISO 6872:2015 (Dentistry – Ceramic materials), the product must meet the requirements for flexural strength, chemical solubility, coefficient of thermal expansion, and radioactivity. The predicate IPS e.max ZirCAD(K051705) meet the requirements of the applicable Class, as detailed in Table under Technological Characteristics.

The performance of INN-CERA meets the requirements of the non-clinical bench testing conducted to support substantial equivalence. Based on the available information, the subject device and the predicates are similar indication for use, material, performance data and biocompatibility.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification that we conclude that substantially equivalent with 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.