Copra Supreme

K233064 · Whitepeaks Dental Solutions GmbH · EIH · Sep 18, 2024 · Dental

Device Facts

• Record ID: K233064
• Device Name: Copra Supreme
• Applicant: Whitepeaks Dental Solutions GmbH
• Product Code: EIH · Dental
• Decision Date: Sep 18, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Copra Supreme zirconia blanks are indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

Device Story

Pre-sintered zirconia blanks (4Y-TZP) used by dental technicians to fabricate custom all-ceramic dental restorations; processed via CAD/CAM milling machines; sintered at temperatures >1450°C; non-sterile; available in white and pre-shaded varieties; intended for anterior and posterior dental applications.

Clinical Evidence

Bench testing only. Physical properties (flexural strength, coefficient of thermal expansion, solubility, radioactivity) tested per ISO 6872:2015. Biocompatibility assessment performed per ISO 10993-1:2018, including cytotoxicity, irritation, sensitization, and genotoxicity testing; all parameters passed.

Technological Characteristics

Material: 4Y-TZP zirconia (ZrO2); Crystal morphology: Tetragonal; Form factor: Discs; Processing: CAD/CAM milling followed by sintering (>1450°C); Standards: ISO 6872:2015 (Type II Class 5), ISO 10993-1:2018; Sterility: Non-sterile.

Indications for Use

Indicated for dental technicians constructing custom all-ceramic restorations for anterior and posterior locations.

Regulatory Classification

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.

Predicate Devices

• Prismatik Dentalcraft Bruxzir Esthetic (K213425)

Reference Devices

• Whitepeaks Copran Zr (K092496)

Submission Summary (Full Text)

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September 18, 2024

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

Re: K233064

Trade/Device Name: Copra Supreme Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: June 19, 2024 Received: June 20, 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.

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"

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(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 OS 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.

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 Rue"). 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-advicecomprehensive-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-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 ([e-mail]) or phone [phone] or 301-796-7100).

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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

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

#### K233064

Device Name Copra Supreme

Indications for Use (Describe)

Copra Supreme zirconia blanks are indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

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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## Whitepeaks Dental Solutions Copra Supreme Zirconia Blanks 510K Summary (K233064) April 7, 2024

Name and Address: Whitepeaks Dental Solutions GmbH Alfredstrasse 81 45130 Essen Germany Contact Person: Oliver Puckert Email: [e-mail] Telephone: [phone]

Name of device: Whitepeaks Dental Solutions Copra Supreme zirconia blanks 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 [phone] [e-mail]

#### Device Description:

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

Copra Supreme disks come in both white and pre-shaded 0M1-D4 in various sizes.

#### Indications for Use:

Copra Supreme zirconia blanks are indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

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

A biocompatibility assessment of Copra Supreme was done in accordance with ISO 10993-1:2018. Cytotoxicity, irritation, sensitization and genotoxicity were tested and passed.

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

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### Primary Predicate Device: Prismatik Dentalcraft Bruxzir Esthetic K213425

### 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 | Copra Supreme white | Copra Supreme 0M1-D4 | Copran Zr Reference Device | Prismatik Dentalcraft Bruxzir Esthetic Predicate Device |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k Number | | | K092496 | K213425 |
| 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 | Copra Supreme zirconia blanks are indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location. | Copra Supreme zirconia blanks are indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location. | 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 friameworks in the anterior and posterior areas Bridge frameworks in the anterior and posterior areas Primary conical crowns and telescopic crowns Cantilevered bridges with a | The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location. |

Zirconia discs from Whitepeaks Dental Solutions

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| | | | having a premolar<br>width<br>Inlays, Onlays,<br>Veneers | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | Pre-sintered<br>zirconia blanks for<br>the fabrication of<br>individual dental<br>restorations.<br>Copra Supreme<br>disks come in both<br>white and pre-<br>shaded 0M1-D4 in<br>various sizes. | Pre-sintered<br>zirconia blanks for<br>the fabrication of<br>individual dental<br>restorations.<br>Copra Supreme<br>disks come in both<br>white and pre-<br>shaded 0M1-D4 in<br>various sizes. | Pre-sintered<br>zirconia blanks for<br>the fabrication of<br>individual dental<br>restorations. | BruxZir®<br>Esthetic blanks<br>are zirconia<br>milling blanks<br>used for the<br>production of<br>esthetic<br>zirconia dental<br>restorations.<br>The high<br>esthetics and<br>high strength of<br>BruxZir®<br>Esthetic<br>restorations<br>make them<br>viable for use in<br>all regions of<br>the mouth. The<br>manufactured<br>dental<br>restorations are<br>made utilizing a<br>CAD/CAM<br>system for<br>design<br>and<br>manufacture.<br>The designed<br>and<br>manufactured<br>dental<br>restorations are<br>then sintered<br>at a high<br>temperature.<br>BruxZir®<br>Esthetic blanks<br>are available in<br>white and pre-<br>shaded |
| | | | | varieties that<br>can be easily<br>adjusted to<br>match the final<br>shade. |
| Basic Design | Discs | Discs | Discs and blocks | Discs |
| Mechanism of<br>Action | Used in a milling<br>machine for<br>fabrication of a<br>dental restoration | Used in a milling<br>machine for<br>fabrication of a<br>dental restoration | Used in a milling<br>machine for<br>fabrication of a<br>dental restoration | Used in a milling<br>machine for a<br>fabrication of a<br>dental<br>restoration |
| Materials | ISO 6872:2015<br>Type II Class 5 | ISO 6872:2015<br>Type II Class 5 | ISO 6872:2015<br>Type II Class 5 | ISO 6872:2015<br>Type II Class 5 |
| Formula | ZrO2 with others | ZrO2 with others | ZrO2 with others | ZrO2 with others |
| Crystal<br>Morphology | Tetragonal | Tetragonal | Tetragonal | Tetragonal |
| Material | 4Y-TZP | 4Y-TZP | 3Y-TZP | 4Y-TZP |
| Processing | Sintering at<br>temperature ><br>1450°C | Sintering at<br>temperature ><br>1450°C | Sintering at<br>temperature ><br>1450°C | Sintering at<br>temperature ><br>1450°C |
| Dimensions | various | various | various | various |
| Single Use | Yes | Yes | Yes | Yes |
| Color | White | Pre-shaded | White | White and Pre-<br>shaded |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Flexural Strength<br>MPa | 1100 | 1100 | 1400 | 980 |
| Fracture<br>Toughness<br>MPa·m1/2 | 3.5 | 3.5 | 5 | 2.7-3.1 |
| Solubility µg/cm² | 6.8 | 6.6-6.8 | 6.7 | <100 |
| Radioactivity | < 0.0102 Bq·g-1<br>238U | Between <0.0096<br>and<br>< 0.0170 Bq·g-1<br>238U | < 0.0117 Bq·g-1<br>238U | No more than 1<br>Bq·g-1<br>238U |

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Conclusion: Copra Supreme zirconia blanks are substantially equivalent to the predicate device. They have the same indications for use, mechanism of action and similar physical properties and formula. The solubility of the reference device and Copra Supreme are the same when variances in test results are considered as all of them fall between 6.6-6.8. The radioactivity of Copra Supreme is less than that of the reference device so does not impact the substantial equivalence since less radioactivity means less of a safety concern. 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

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predicate device are covered by the reference device. Slight differences in size and shape do not change their substantial equivalence to the predicate devices.