zirconia layering porcelain system layering ceramic powders and pastes are used in dental laboratories by the dental technician to create ceramic restorations.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary are for "zirkon; structure; LFU shades, stains and glazes," which are dental ceramic materials (porcelain powder for clinical use), not a medical device that relies on an algorithm or AI for diagnostic or treatment assistance. Therefore, the document does not contain any information regarding acceptance criteria related to device performance in the context of AI/algorithm a medical device, nor does it describe a study to prove such performance.

The "acceptance criteria" and "study" described in the input prompt are typically associated with AI/ML-based medical devices or diagnostic tools where performance metrics like sensitivity, specificity, or reader improvement are critical for demonstrating safety and effectiveness.

The information provided in the FDA document focuses on the equivalence of the dental ceramic materials to a predicate device based on:

Intended Use: Types of dental restorations (crowns, veneers, inlays, onlays).
Technological Characteristics: Physical state (powder/paste), material composition (silicate glass ceramics), and classification according to ISO 6872:2019.
Bench Testing: Compliance with physical properties (flexural strength, chemical solubility, thermal expansion, glass transition temperature, radioactivity) and biocompatibility according to ISO 7405:2018 and ISO 10993:2018.

Therefore, it is impossible to extract the requested information (table of acceptance criteria with device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text, as these concepts are not applicable to the type of device described.

Summary

FDA 510(k) Clearance Letter - K251084

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

June 5, 2025

estetic ceram ag
℅ Anna Pocsai
Consultant
novineon CRO
Friedrich-Miescher-Straße 9
Tuebingen, Baden-Württemberg 72076
Germany

Re: K251084
Trade/Device Name: zirkon; structure; LFU shades, stains and glazes
Regulation Number: 21 CFR 872.6660
Regulation Name: Porcelain Powder For Clinical Use
Regulatory Class: Class II
Product Code: EIH
Dated: April 9, 2025
Received: April 9, 2025

Dear Anna Pocsai:

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 (the 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 available 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.

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K251084 - Anna Pocsai Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251084 - Anna Pocsai Page 3

assistance/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,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE., RAC, CQIA
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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Food and Drug Administration
Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Submission Number (if known)
K251084

Device Name
zirkon; structure; LFU shades, stains and glazes

Indications for Use (Describe)
Types of restorations:

Anterior and posterior crowns
Veneers, inlays, onlays.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Confidential
Dental Ceramics
Abbreviated Premarket Notification [510(k)]
estetic ceram AG

K251084
510(k) Summary

This summary of 510(k) for the subjective device equivalence information is being submitted in accordance with the requirements of 21 C.F.R. 807.92.

Date summary prepared: May 06, 2025

Applicant information:
Name: estetic ceram ag
Address: Landstrasse 109, 9495 Triesen, Liechtenstein
Tel: + 4232374851
Contact person and title: Dr. Michael Reise, Head of Research & Production
E-mail: michael.reise@esteticceram.com

Contact person:
Name: novineon CRO
Address: Friedrich-Miescher Str 9, 72076 Tübingen
Tel: +49707198979204
Contact person and title: Anna Pocsai, Consultant
E-mail: anna.pocsai@novineon.com

Subject device
Trade name: zirkon; structure; LFU shades, stains and glazes
Common Name: dental ceramic
Product code: EIH
FDA Regulation: 21 CFR 872.6660 – Porcelain Powder for Clinical Use
Device classification: Class II

1. Device Description

zirconia layering porcelain system layering ceramic powders and pastes are used in dental laboratories by the dental technician to create ceramic restorations.

2. Indications for use

Types of restorations:

Anterior and posterior crowns
Veneers, inlays, onlays.

3. Comparison to Predicate Devices

The legally marketed device to which estetic ceram is claiming equivalence is identified as Soprano 10, Soprano surface and Soprano, manufactured by Cendres+Metaux SA, Switzerland. The Soprano system consists of layering ceramics for dental restorations.

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Confidential
Dental Ceramics
Abbreviated Premarket Notification [510(k)]
estetic ceram AG

Specifically, equivalence is claimed between the following products:

PFZ zirkon and Soprano10
structure und stains LFU and Soprano Surface
Stains, shades & glaze LFU and Soprano

Substantial equivalence is based on intended use, technological characteristics, material composition, and conformity with consensus standards, as described the tables below:

	Subject device	Predicate device
Product name	PFZ zirkon	Soprano 10
Manufacturer	estetic ceram AG	Cendres+Métaux SA
Indications for use	Types of restorations:1. Anterior and posterior crowns2. Veneers, inlays, onlays.	• Veneers• Inlays and onlays• Partial crowns• 3-pontic bridge in anterior tooth region• 3-pontic bridge in the premolar region up to max. 2nd premolar as a permanent abutment• Anterior and posterior tooth crowns
Technical Characteristics
Physical state	Powder	Powder
Material	Silicate glass ceramics,Main constituents: SiO2, Al2O3, K2O, Na2O, CaO, B2O3	Silicate glass ceramic mainly composed of SiO2, Al2O3, Li2O, P2O5, K2O, CaO, B2O3
Classification acc to 6872:2019	Type 1Class 1b	Type 1Class 1b

3.1. structure

	Subject device	Predicate device
Product name	structure, LFU shades, stains and glazes	Soprano (surface)
Manufacturer	estetic ceram AG	Cendres+Métaux SA
Indications for use	Types of restorations:1. Anterior and posterior crowns2. 3. Veneers, inlays, onlays.	• Veneers• Inlays and onlays• Partial crowns• Anterior and posterior tooth crowns
Technical Characteristics
Physical state	Powder or paste	Powder or paste
Material	Silicate glass ceramics,Main constituents: SiO2, Al2O3, K2O, Na2O, Li2O, B2O3	Silicate glass ceramic mainly composed of SiO2, Al2O3, Li2O, P2O5, K2O, CaO, B2O3

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Confidential
Dental Ceramics
Abbreviated Premarket Notification [510(k)]
estetic ceram AG

	Subject device	Predicate device
Product name	structure, LFU shades, stains and glazes	Soprano (surface)
Classification acc to 6872:2019	Type 1Class 1b	Type 1Class 1b

3.2. Bench Testing

This 510(k)submission includes performance testing supporting compliance to International Standard ISO 6872:2015 as recognized by FDA. Measured parameters in a representative sample of the products included:

Flexural strength
Chemical Solubility
Coefficient of Thermal Expansion
Glass Transition Temperature, and
Radioactivity of 238U.

The results show product compliance to the requirements of ISO 6872:2015.

The subject devices is surface contacting material with contact with the oral mucosa with contact duration of more than 30 days (permanent contact). Biocompatibility evaluation was performed according to ISO 7405:2018 and ISO 10993:2018.

4. Conclusions

zirconia layering porcelain system has been demonstrated to be substantially equivalent to the 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.