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.)

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.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called "Copran Zri," which consists of machinable zirconia discs for dental restorations. The document asserts that this device is substantially equivalent to a predicate device, Ivoclar IPS e.max ZirCad MO (K051705), and references Whitepeaks Copran Zr (K092496).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

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

The document implicitly uses the performance of the predicate and reference devices, as well as standards like ISO 6872:2015, to establish acceptance criteria. The table below compiles the reported device performance for Copran Zri in comparison to these.

Acceptance Criteria (from ISO 6872:2015 and Predicate/Reference)	Copran Zri Performance	Notes
Physical Properties
ISO 6872:2015 Classification	Type II Class 5	Copran Zri, Copran Zri Light, Medium and Intense all meet this classification, which is consistent with the reference and predicate devices. This standard dictates properties for ceramic materials for dental restorations.
Bending/Flexural Strength (MPa)	1400	Reported as 1400 MPa for Copran Zri. The predicate device (Ivoclar ZirCad MO) has 1150 MPa, and the reference device (Copran Zr) has 1400 MPa. Copran Zri meets or exceeds the predicate.
Fracture Toughness (MPa·m1/2)	5	Reported as 5 MPa·m1/2 for Copran Zri. The predicate device has >5.1 MPa·m1/2, and the reference device has 5 MPa·m1/2. Copran Zri is comparable to the reference and close to the predicate.
Solubility (µg/cm²)	6.7	Reported as 6.7 µg/cm² for Copran Zri. The predicate device has <100 µg/cm², and the reference device has 6.7 µg/cm². Copran Zri significantly exceeds the predicate in terms of lower solubility (which is better).
CTE (25-500°C) 10-6/K	10.2	Reported as 10.2 10-6/K for Copran Zri. The predicate device has 10.5 ± 0.5 10-6/K, and the reference device has 10.2 10-6/K. Copran Zri is within the range of the predicate and matches the reference.
Radioactivity (Bq·g-1)	< 0.0117 Bq·g-1 (238U)	Reported as < 0.0117 Bq·g-1 (238U) for Copran Zri. The predicate device does not have this present in labeling (implying it meets standards or is not relevant). The reference device matches Copran Zri. This indicates compliance with relevant safety standards.
Biocompatibility
ISO 10993-1:2018 Compliance	Compliant	A biocompatibility assessment was done in accordance with ISO 10993-1:2018. The document implies successful completion.

The statement: "The physical properties of Copran Zri were tested according to ISO 6872:2015 and all parameters meet the standard" and "Both the subject devices, the predicate devices and the reference devices physical properties meet ISO 6872:2015" confirms that meeting this standard served as the primary acceptance criteria for physical properties.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document states: "The physical properties of Copran Zri were tested according to ISO 6872:2015". However, it does not specify the sample size used for these tests.
The data provenance is also not stated. We know the manufacturer is Whitepeaks Dental Solutions GmbH from Germany, so the testing was likely conducted in Germany or a location associated with their operations or chosen testing facilities. It's also not specified if the testing was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable to this type of device submission. The device is a material for dental restorations. Its performance is evaluated through standardized physical, chemical, and biological tests, not through expert reading of images or diagnoses. Therefore, there's no "ground truth" derived from expert consensus in the clinical sense mentioned in the prompt.

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

This is not applicable for the same reasons as point 3. The evaluation is based on objective measurements against established international standards (ISO 6872:2015, ISO 10993-1:2018), not on subjective expert interpretation requiring adjudication.

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:

This is not applicable. The device is a material for dental restorations, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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

This is not applicable as the device is not an algorithm or software.

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

The "ground truth" for evaluating this device's performance is established by international standards for dental materials (specifically ISO 6872:2015 for ceramic materials) and biocompatibility standards (ISO 10993-1:2018). These standards define the acceptable range or minimum/maximum values for critical physical and biological properties. The results of laboratory tests are compared directly against these numerical benchmarks.

8. The sample size for the training set:

This is not applicable. The device is not an AI model, and therefore, there is no "training set."

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

This is not applicable for the same reason as point 8.

Summary

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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 premolarwidthInlays, Onlays,Veneers
Device Description	Pre-sinteredzirconia blanks forthe fabrication ofindividual dentalrestorations.	Pre-sinteredzirconia blanks forthe fabrication ofindividual dentalrestorations.	Pre-sinteredzirconia blanks forthe fabrication ofindividual dentalrestorations.	Pre-sinteredzirconia blanksfor thefabrication ofindividual dentalrestorations.
Basic Design	Discs	Discs	Discs and blocks	Discs and blocks
Mechanism ofAction	Used in a millingmachine forfabrication of adental restoration	Used in a millingmachine forfabrication of adental restoration	Used in a millingmachine forfabrication of adental restoration	Used in a millingmachine forfabrication of adentalrestoration
Materials	ISO 6872:2015Type II Class 5	ISO 6872:2015Type II Class 5	ISO 6872:2015Type II Class 5	ISO 6872:2015Type II Class 5
Formula	ZrO2 with others	ZrO2 with others	ZrO2 with others	ZrO2 with others
CrystalMorphology	Tetragonal	Tetragonal	Tetragonal	Tetragonal
Material	3Y-TZP	3Y-TZP	3Y-TZP	3Y-TZP
Processing	Sintering attemperature >1450°C	Sintering attemperature >1450°C	Sintering attemperature >1450°C	Sintering attemperature >1450°C
Disc Dimensions	Discs 95mmdiameter inthicknesses 10-25mmDiscs 98mmdiameter inthicknesses 10-25mm	Discs 95mmdiameter inthicknesses 10-25mmDiscs 98mmdiameter inthicknesses 10-25mm	Discs 95mmdiameter inthicknesses 10-25mmDiscs 98mmdiameter inthicknesses 10-25mm	Discs 98mmdiameter inthicknesses 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 StrengthMPa	1400	1400	1400	1150
FractureToughnessMPa·m1/2	5	5	5	>5.1
Solubility µg/cm²	6.7	6.7	6.7	<100
CTE (25-500°C)10-6/K	10.2	10.2	10.2	10.5 ± 0.5

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Radioactivity	< 0.0117 Bq·g-1	< 0.0117 Bq·g-1	< 0.0117 Bq·g-1	Not present inlabeling
	238U	238U	238U

Conclusion: Copran Zri are substantially equivalent to the predicate device. They have the same indications for use, mechanism of action and similar physical properties and formula. Both the subject devices, the predicate devices and the reference devices physical properties meet ISO 6872:2015. Differences in shapes and sizes between the subject devices and the predicate device are covered by the reference device. Slight differences in diameter do not change their substantial equivalence to the predicate devices as these differences do not change the materials properties in any way, it is just to allow for machine fit.

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.