(57 days)
Not Found
No
The document describes a zirconia layering porcelain system used in dental laboratories. It does not mention any AI, DNN, or ML technologies in its description, intended use, or performance studies.
No
The device is a material used by dental technicians to create dental restorations, not a device used to directly treat a patient's medical condition. It is a component of a restoration, not a therapeutic device itself.
No.
The device is a zirconia layering porcelain system used to create ceramic restorations in dental laboratories; it does not involve diagnosing conditions or diseases.
No
The device description indicates it is a "zirconia layering porcelain system layering ceramic powders and pastes" used to create "ceramic restorations." The performance studies include physical material properties (flexural strength, chemical solubility, etc.) and biocompatibility, which are characteristics of a physical material, not software. There is no mention of software functions, algorithms, or digital processing.
No
The device is a zirconia layering porcelain system used for creating dental restorations in a dental laboratory; it does not analyze or test samples derived from the human body.
N/A
Intended Use / Indications for Use
Types of restorations:
- Anterior and posterior crowns
- Veneers, inlays, onlays.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
zirconia layering porcelain system layering ceramic powders and pastes are used in dental laboratories by the dental technician to create ceramic restorations.
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 laboratories by the dental technician
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
FDA 510(k) Clearance Letter - K251084
Page 1
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.
Page 2
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-
Page 3
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
Page 4
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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"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."
Page 5
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
Predicate device
Device name: Soprano 10©, Soprano©
510(k) number: K192551
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.
Page 6
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: |
- Anterior and posterior crowns
- 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 1
Class 1b | Type 1
Class 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: |
- Anterior and posterior crowns
-
- 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 |
- Veneers, inlays, onlays. | • Veneers
Page 7
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 1 | |
| Class 1b | Type 1 | |
| Class 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.