Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the material properties and intended use of zirconia discs for dental restorations, with no mention of AI or ML technology.

Therapeutic

No
The device is described as pre-sintered zirconia blanks for the fabrication of individual dental restorations (crowns, onlays, bridges, inlay bridges), which are prosthetics, not therapeutic devices.

Diagnostic

No
Explanation: The device is a material (zirconia discs) used for the preparation of dental restorations, not for diagnosing medical conditions. It is used in the treatment phase, not the diagnostic phase.

SaMD (Software as a Medical Device)

No

The device description clearly states it is "Pre-sintered zirconia blanks for the fabrication of individual dental restorations," which are physical materials, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
Device Description: The description clearly states that Copran Zri consists of "machinable zirconia discs for the preparation of full ceramic crowns, onlays and 3-and 4-unit bridges and inlay bridges." These are materials used to fabricate dental restorations, which are implanted or placed in the mouth.
Intended Use: The intended use is for creating dental restorations, not for performing diagnostic tests on biological samples.
Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting biomarkers, or providing diagnostic information.

Therefore, Copran Zri is a dental material used for fabrication, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Copran Zri consists of machinable zirconia discs for the preparation of full ceramic crowns, onlays and 3-and 4-unit bridges and inlay bridges (anterior and molar.)

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

EIH

Device Description

Pre-sintered zirconia blanks for the fabrication of individual dental restorations.

Copran Zri disks come in both white and pre-shaded light, medium or intense in 95 and 98 mm diameter in thicknesses from 10-25mm.

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

Not Found

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)

The physical properties of Copran Zri were tested according to ISO 6872:2015 and all parameters meet the standard. Testing included bending strength, solubility, radioactivity and thermal expansion coefficient.

A biocompatibility assessment of Copran Zri was done in accordance with ISO 10993-1:2018.

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.

K051705

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.

K092496

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

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 contains 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.

June 24, 2024

Whitepeaks Dental Solutions GmbH % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172

Re: K232952

Trade/Device Name: Copran Zri Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 1, 2024 Received: April 2, 2024

Dear Angela Blackwell:

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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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 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-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 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.

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-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).

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Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, MChE, 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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Indications for Use

510(k) Number (if known) K232952

Device Name Copran Zri

Indications for Use (Describe)

Copran Zri consists of machinable zirconia discs for the preparation of full ceramic crowns, onlays and 3-and 4-unit bridges and inlay bridges (anterior and molar.)

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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K232952 Whitepeaks Dental Solutions Copran Zri discs 510K Summary April 1, 2024

Name and Address: Whitepeaks Dental Solutions GmbH Alfredstr. 81 45130 Essen Germany Contact Person: Oliver Puckert Email: o.puckert@whitepeaks-dental.de Telephone: +49(281) 206458-11

Name of device: Whitepeaks Dental Solutions Copran Zri discs Common name: zirconia blanks Classification Name: Porcelain powder for clinical use CFR: 21 CFR 872.6660 Primary Product Code: EIH

Submission Contact:

Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com

Device Description:

Pre-sintered zirconia blanks for the fabrication of individual dental restorations.

Copran Zri disks come in both white and pre-shaded light, medium or intense in 95 and 98 mm diameter in thicknesses from 10-25mm.

Indications for Use:

Copran Zri consists of machinable zirconia discs and blocks for the preparation of full ceramic crowns, onlays and 3-and 4-unit bridges and inlay bridges (anterior and molar.)

Testing Summary: The physical properties of Copran Zri were tested according to ISO 6872:2015 and all parameters meet the standard. Testing included bending strength, solubility, radioactivity and thermal expansion coefficient.

A biocompatibility assessment of Copran Zri was done in accordance with ISO 10993-1:2018.

Mechanism of Action: Used in a milling machine for fabrication of a dental restoration

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Predicate Device: Ivoclar IPS e.max ZirCad MO K051705

Reference Devices: Whitepeaks Copran Zr K092496

Substantial Equivalence:

The zirconia blanks have similar ingredients to the predicate and reference devices, the same indications for use, and similar physical parameter testing.

Name	Copran Zri	Copran Zri Light, Medium and Intense	Copran Zr Reference Device	Ivoclar ZirCad MO Predicate Device
510k Number	K232952	K232952	K092496	K051705
Common Name	Zirconia blanks	Zirconia blanks	Zirconia blanks	Zirconia blanks
Classification Name	Porcelain powder for clinical use	Porcelain powder for clinical use	Porcelain powder for clinical use	Porcelain powder for clinical use
Class	II	II	II	II
Product Code	EIH	EIH	EIH	EIH
CFR	872.6660	872.6660	872.6660	872.6660
Indications for Use	Copran Zri consists of machinable zirconia discs for the preparation of full ceramic crowns, onlays and 3-and 4-unit bridges and inlay bridges (anterior and molar.)	Copran Zri consists of machinable zirconia discs for the preparation of full ceramic crowns, onlays and 3-and 4-unit bridges and inlay bridges (anterior and molar.)	Copran Zr Zirconia blanks are presintered blanks for CAD CAM or manual milling, made from biocompatible, tetragonal and polycrystalline zirconiumdioxyde. Milling blanks designed for: Crown frameworks in the anterior and posterior areas Bridge frameworks in the anterior and posterior areas Primary conical crowns and telescopic crowns Cantilevered bridges with a max, of one pontic	IPS e.max ZirCAD consists of machinable zirconia blocks for the preparation of full ceramic crowns, onlays and 3-and 4-unit bridges and inlay bridges (anterior and molar.)

Zirconia discs from Whitepeaks Dental Solutions

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| | | | having a premolar
width
Inlays, Onlays,
Veneers | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Device Description | Pre-sintered
zirconia blanks for
the fabrication of
individual dental
restorations. | Pre-sintered
zirconia blanks for
the fabrication of
individual dental
restorations. | Pre-sintered
zirconia blanks for
the fabrication of
individual dental
restorations. | Pre-sintered
zirconia blanks
for the
fabrication of
individual dental
restorations. |
| Basic Design | Discs | Discs | Discs and blocks | Discs and blocks |
| Mechanism of
Action | Used in a milling
machine for
fabrication of a
dental restoration | Used in a milling
machine for
fabrication of a
dental restoration | Used in a milling
machine for
fabrication of a
dental restoration | Used in a milling
machine for
fabrication of a
dental
restoration |
| Materials | ISO 6872:2015
Type II Class 5 | ISO 6872:2015
Type II Class 5 | ISO 6872:2015
Type II Class 5 | ISO 6872:2015
Type II Class 5 |
| Formula | ZrO2 with others | ZrO2 with others | ZrO2 with others | ZrO2 with others |
| Crystal
Morphology | Tetragonal | Tetragonal | Tetragonal | Tetragonal |
| Material | 3Y-TZP | 3Y-TZP | 3Y-TZP | 3Y-TZP |
| Processing | Sintering at
temperature >
1450°C | Sintering at
temperature >
1450°C | Sintering at
temperature >
1450°C | Sintering at
temperature >
1450°C |
| Disc Dimensions | Discs 95mm
diameter in
thicknesses 10-
25mm
Discs 98mm
diameter in
thicknesses 10-
25mm | Discs 95mm
diameter in
thicknesses 10-
25mm
Discs 98mm
diameter in
thicknesses 10-
25mm | Discs 95mm
diameter in
thicknesses 10-
25mm
Discs 98mm
diameter in
thicknesses 10-
25mm | Discs 98mm
diameter in
thicknesses 10-
25mm |
| Single Use | Yes | Yes | Yes | Yes |
| Color | None | Pre-shaded | None | Pre-shaded |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Flexural Strength
MPa | 1400 | 1400 | 1400 | 1150 |
| Fracture
Toughness
MPa·m1/2 | 5 | 5 | 5 | >5.1 |
| Solubility µg/cm² | 6.7 | 6.7 | 6.7 |