ICE CERAMICS, ICE CERAMICS TISSUE, ICE CERAMICS DENTINE +, ICE CERAMICS DYNAMIC DENTINE, FRESCO ENAMEL, FRESCO GINGIVA, FRESCO, FRESCO DENTINE + and FRESCO DYNAMIC DENTINE are type I ceramics for coating, staining and glazing dental restorations made of final-sintered zirconia. They are conceived for patients who require dental restorations in zirconia, such as single crowns, bridges, inlays, onlays or veneers.
ICE STAINS, ICE STAINS PRETTAU®, ICE STAINS GLAZE FLUO and ICE STAINS 3D are type I ceramics for coating, staining and glazing dental restorations made of final-sintered zirconia. They are conceived for patients who require dental restorations in zirconia, such as single crowns, bridges, inlays, onlays or veneers.

Device Description

All devices included in this submission are dental glass ceramics. There are different device types from three device groups: ICE Ceramics Group, ICE Stains Group, and Fresco Group. The devices are supplied in form of powders or pastes and are available in different colors and/ or in different quantity sizes. Specific accessories are supplied for mixing or changing viscosity.

AI/ML Overview

The provided text describes a 510(k) premarket notification for dental glass ceramics (ICE Ceramics, ICE Stains, Fresco) and includes non-clinical testing data to establish substantial equivalence to a predicate device. However, it does not describe a study involving human readers or AI assistance, nor does it present acceptance criteria in terms of diagnostic performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested items cannot be answered from the provided document. The device in question is a dental material, not an AI-powered diagnostic tool.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are presented as performance requirements according to the relevant ISO standards for dental ceramics.

Acceptance Criteria (from ISO 6872)	Reported Device Performance (New Devices)	Meeting Criteria
Flexural strength ≥ 50 MPa	Flexural strength ≥ 50 MPa	Yes
Chemical solubility < 100 µg/cm²	Chemical solubility < 100 µg/cm²	Yes

Additional Acceptance Criteria/Performance for Biocompatibility:
The device's biocompatibility was established according to ISO 10993-1 and ISO 10993-5, indicating it met the requirements of these standards. Specific numerical performance values are not provided, only that it was "established."

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

The document does not specify the sample sizes (e.g., number of restorations or test specimens) used for the non-clinical physical and chemical testing. It also does not mention data provenance as these are laboratory tests, not patient data studies.

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

Not applicable. Ground truth for dental material properties is established through adherence to standardized laboratory test methods (e.g., ISO 6872) and measurements, not expert consensus in the diagnostic sense.

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

Not applicable. Adjudication methods are relevant for diagnostic studies where human interpretation is involved.

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

No MRMC study was done. This document describes a dental material, not an AI-assisted diagnostic device.

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For physical and chemical properties, the ground truth is established by standardized laboratory measurements as defined by ISO 6872 for flexural strength and chemical solubility, and ISO 10993 for biocompatibility.

8. The sample size for the training set

Not applicable. This device is a dental material, not a machine learning model.

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

Not applicable. This device is a dental material, not a machine learning model.

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.

December 14, 2022

Zirkonzahn srl Sandra Leitner Regulatory Affairs Responsible Via An der Ahr 7 Gais, BZ 39030 Italy

Re: K213722

Trade/Device Name: ICE Ceramics, ICE Stains, Fresco Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: November 10, 2022 Received: November 14, 2022

Dear Sandra Leitner:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

Bobak Shirmohammadi -S

For 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) K213722

Device Name ICE Ceramics, ICE Stains and Fresco

Indications for Use (Describe)

ICE STAINS, ICE STAINS PRETTAU®, ICE STAINS GLAZE FLUO and ICE STAINS 3D are type I ceramics for coating, staining and glazing dental restorations made of final-sintered zirconia. They are conceived for patients who require dental restorations in zirconia, such as single crowns, bridges, inlays, onlays or veneers.

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)

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Section 05 510(k) Summary - K213722

510(k) Summary

APPLICANT

Zirkonzahn srl Via An der Ahr 7 Gais, ITALY 39030 Phone: +39 0474 066 660 Fax: +39 0474 066 661 E-mail: info@zirkonzahn.com

CONTACT PERSON

Julian Steger Chief Executive Officer Zirkonzahn srl Via An der Ahr 7 Gais, ITALY 39030 Phone: +39 0474 066 660 Fax: +39 0474 066 661 E-mail: julian.steger@zirkonzahn.com

DATE SUMMARY PREPARED: December 13, 2022

DEVICE IDENTIFICATION

Trade/Proprietary Name:	ICE Ceramics, ICE Stains and Fresco
Regulation Number:	21 CFR 872.6660
Common Name:	Powder, Porcelain
Classification Name:	Porcelain Powder for Clinical use
Class:	II
Product Code:	EIH
Panel:	Dental

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LEGALLY MARKETED PREDICATE DEVICE

Company:	Zirkonzahn srl
Device Name:	Zirkonzahn Ice
Product Code:	EIH
510(k) Number:	K061851

INDICATIONS FOR USE

DEVICE DESCRIPTION

All devices included in this submission are dental glass ceramics. There are different

device types from three device groups:

ICE Ceramics Group:

ICE Ceramics
ICE Ceramics Tissue
ICE Ceramics Dentine +
. ICE Ceramics Dynamic Dentine

ICE Stains Group:

. ICE Stains
ICE Stains Prettau® ●
ICE Stains 3D ●
ICE Stains Glaze Fluo .

Fresco Group:

Fresco ●
Fresco Gingiva
Fresco Enamel ●
Fresco Dentine +
Fresco Dynamic Dentine ●

The above mentioned devices are supplied in form of powders or pastes and are available in different colors and/ or in different quantity sizes. The users can choose among the different options according to their requirements and preferences. Furthermore specific accessories are supplied to optimize the working procedure:

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ICE BUILD UP LIQUID is an accessory used for mixing of ICE CERAMICS, ICE CERAMICS TISSUE, ICE CERAMICS DENTINE + and ICE CERAMICS DYNAMIC DENTINE. FRESCO LIQUID and FRESCO GEL are accessories used to change the viscosity of FRESCO ENAMEL, FRESCO GINGIVA, FRESCO, FRESCO DENTINE + and FRESCO DYNAMIC DENTINE products.

ICE STAIN LIQUID is an accessory used to freshen up ICE STAINS und ICE STAINS PRETTAU®; REFRESHING LIQUID 3D is an accessory used to freshen up ICE STAINS 3D; REFRESHING LIQUID GLAZE FLUO is an accessory used to freshen up ICE STAINS GLAZE FLUO.

All these devices are used by specifically trained personnel to manufacture customized dental restorations.

DISCUSSION OF NON CLINCAL TESTS

Non clinical testing was performed to determine the physical properties of the subject device. Performance testing was conducted in accordance with the International Standard ISO 6872 and the results show that the devices are well suited for their intended use. Furthermore, biocompatibility was established in according to ISO 10993-1 and ISO 10993-5.

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COMPARISON TABLE

Devices	New Devices:ICE Ceramics, ICE Stains and FrescoK213722	Predicate devices:Zirkonzahn IceK061851	Comparison
Company	Zirkonzahn srl	Zirkonzahn srl
Product Code	EIH	EIH	Same
RegulationNumber	872.6660	872.6660	Same
Regulation Name	Porcelain powder for clinical use	Porcelain powder for clinical use	Same
Indications foruse	ICE CERAMICS, ICE CERAMICS TISSUE, ICE CERAMICSDENTINE +, ICE CERAMICS DYNAMIC DENTINE, FRESCOENAMEL, FRESCO GINGIVA, FRESCO, FRESCO DENTINE + andFRESCO DYNAMIC DENTINE are type I ceramics for coating,staining and glazing dental restorations made of final-sinteredzirconia. They are conceived for patients who require dentalrestorations in zirconia, such as single crowns, bridges, inlays, onlaysor veneers.ICE STAINS, ICE STAINS PRETTAU®, ICE STAINS GLAZE FLUOand ICE STAINS 3D are type I ceramics forcoating, staining and glazing dental restorations made of final-sinteredzirconia. They are conceived for patients whorequire dental restorations in zirconia, such as single crowns, bridges,inlays, onlays or veneers.	Metal free single posterior crowns,multiple unit anteriorcrowns/bridges, inlays, onlaysbonded dental restorations.	SimilarZirkonzahn Ice contains asystem of devices(including zirconia blanks,coloring liquids), not onlydental ceramics, but thenew as well as thepredicate devices areintended to veneer /individualize dentalframeworks.
Sizes of dentalframeworks	All, dependent on zirconia device where applied	All, dependent on zirconia devicewhere applied	Same
Chemicalcomposition	Glass ceramic, other metallic oxides, with pigments	Glass ceramic, other metallic oxides, with pigments	Similar
Biocompatibility	ISO 10993-1ISO 10993-5	Not specified in K061851	Similar
Tested accordingto ISO 6872	Flexural strength ≥ 50 MPaChemical solubility < 100 µg/cm²	Flexural strength ≥ 50 MPaChemical solubility < 100 µg/cm²	Similar
Classificationacc. to ISO 6872	Type 1, class 1b	Type 1, class 1b	Same
Principles ofOperation	The devices can be applied in several layers on final-sinteredzirconia structures followed by firing processes. Subsequently,the dental structures are finalized by manual grinding andpolishing.	The devices can be applied in several layers on final-sinteredzirconia structures followed by firing processes. Subsequently, thedental structures are finalized by manual grinding and polishing.	Same
Shades	Dentine shades (Vita dentine shades A1 –D4 etc.)Intensive colorsGlazes	Dentine shades (Vita dentine shades A1 -D4 etc.)Intensive colorsGlazes	Similar
Form	Powders, pastes and liquids	Powders, pastes and liquids	Same
StorageConditions	In tightly sealed original packaging with a maximal temperatureof 35 °C for ICE Stains, Fresco and accessory liquids.If stored too cold, the liquid may freeze and must be defrostedbefore use.If stored too warm, the pastes may dry out.	Storage temperature between10 °C and 30 °C	Differences do not havean effect on final medicaldevice, thereforedifference not significant.

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SUBSTANTIAL EQUIVALENCE DISCUSSION

The new devices and the predicate devices are similar in function and intended use. The differences noted do not raise any new questions about safety and effectiveness. Therefore, Zirkonzahn concludes that the proposed devices are substantially equivalent to the predicate.

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.