Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a ceramic material used in a 3D printing process for dental restorations. There is no mention of AI or ML in the intended use, device description, or performance studies. The process relies on an STL file generated from patient data, but the generation of this file is not described as involving AI/ML.

Therapeutic

No
This device is a material used by dental technicians to fabricate custom-made all-ceramic restorations and does not directly provide therapeutic benefits to a patient.

Diagnostic

No

The device is a material (zirconia powder and binder mixture) used by dental technicians to fabricate custom-made all-ceramic restorations (e.g., crowns, bridges) using a 3D printer. It is a manufacturing material, not a diagnostic tool used to identify or analyze a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly states that INNI-CERA is a "mixture of zirconia powder and binder" and a "photocurable mixture," which are physical materials used in a 3D printing process. While it uses an STL file (software output) and a 3D printer (hardware), the core regulated component described is a material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the construction of custom-made all-ceramic dental restorations (copings, crowns, inlays, onlays, veneers, bridges) by dental technicians. This is a manufacturing process for a medical device that will be placed in the patient's mouth.
Device Description: The device is a material (mixture of zirconia powder and binder) used in a 3D printer to fabricate these dental restorations. It is a component of the manufacturing process, not a test performed on a biological sample to provide diagnostic information.
Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition. It is purely a material for creating a physical restoration.
No Biological Sample Testing: IVDs are designed to test biological samples (blood, urine, tissue, etc.). This device is used to create a physical object.

In summary, INNI-CERA is a material used in the manufacturing of dental prosthetics, which are medical devices, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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)

Product codes (comma separated list FDA assigned to the subject device)

EIH

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental technicians

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench Test: 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 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

No clinical performance testing was performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Flexural Strength: >300 MPa (meeting ISO 6872 requirements)
Chemical Solubility:

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.

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)
-------------------------------------------------

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:

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.

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