(383 days)
Not Found
No
The summary describes dental glass ceramics for coating and staining zirconia restorations. There is no mention of software, algorithms, or any technology that would suggest AI/ML is involved. The performance studies focus on physical properties and biocompatibility.
No
The device is a dental ceramic material used for coating, staining, and glazing dental restorations, not for treating diseases or conditions.
No
The device description indicates that these are dental glass ceramics used for coating, staining, and glazing dental restorations. This suggests a restorative or prosthetic function rather than a diagnostic one.
No
The device description explicitly states the devices are "dental glass ceramics" supplied as "powders or pastes," indicating a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these are ceramics for coating, staining, and glazing dental restorations made of zirconia. This is a material used in the fabrication of dental prosthetics, not a diagnostic test performed on biological samples.
- Device Description: The description confirms they are dental glass ceramics supplied as powders or pastes for use in dental procedures.
- Lack of Diagnostic Purpose: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis, monitoring, or treatment of a disease or condition based on such analysis.
- Performance Studies: The performance studies focus on physical properties (flexural strength, chemical solubility) and biocompatibility, which are relevant to the material's use in dental restorations, not diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for medical purposes. This device is a material used in the creation of dental prosthetics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
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:
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.
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
specifically trained personnel
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural strength ≥ 50 MPa
Chemical solubility
§ 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known) K213722
Device Name ICE Ceramics, ICE Stains and Fresco
Indications for Use (Describe)
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 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.
| 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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3
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 |
4
LEGALLY MARKETED PREDICATE DEVICE
| Company: | Zirkonzahn srl |
|---|---|
| Device Name: | Zirkonzahn Ice |
| Product Code: | EIH |
| 510(k) Number: | K061851 |
INDICATIONS FOR USE
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 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:
5
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.
6
COMPARISON TABLE
| Devices | New Devices:
ICE Ceramics, ICE Stains and Fresco
K213722 | Predicate devices:
Zirkonzahn Ice
K061851 | Comparison |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Zirkonzahn srl | Zirkonzahn srl | |
| Product Code | EIH | EIH | Same |
| Regulation
Number | 872.6660 | 872.6660 | Same |
| Regulation Name | Porcelain powder for clinical use | Porcelain powder for clinical use | Same |
| Indications for
use | 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. | Metal free single posterior crowns,
multiple unit anterior
crowns/bridges, inlays, onlays
bonded dental restorations. | Similar
Zirkonzahn Ice contains a
system of devices
(including zirconia blanks,
coloring liquids), not only
dental ceramics, but the
new as well as the
predicate devices are
intended to veneer /
individualize dental
frameworks. |
| Sizes of dental
frameworks | All, dependent on zirconia device where applied | All, dependent on zirconia device
where applied | Same |
| Chemical
composition | Glass ceramic, other metallic oxides, with pigments | Glass ceramic, other metallic oxides, with pigments | Similar |
| Biocompatibility | ISO 10993-1
ISO 10993-5 | Not specified in K061851 | Similar |
| Tested according
to ISO 6872 | Flexural strength ≥ 50 MPa
Chemical solubility