Copra Smile, Copra Supreme Hyperion

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. June 20, 2024 Whitepeaks Dental Solutions GmbH % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172 Re: K233158 Trade/Device Name: Copra Smile, Copra Supreme Hyperion Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 21, 2024 Received: May 22, 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. {1}------------------------------------------------ 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). {2}------------------------------------------------ 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 {3}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. ## 510(k) Number (if known) ## K233158 Device Name Copra Smile and Copra Supreme Hyperion Indications for Use (Describe) Copra Smile consists of machinable zirconia discs and blocks for preparation of single crowns, bridges with maximum of one pontic between two crowns and inlays, onlays and veneers. Copra Supreme Hyperion 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). 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ #### Whitepeaks Dental Solutions Copra Smile and Copra Supreme Hyperion 510K Summary K233158 September 24, 2023 Name and Address: Whitepeaks Dental Solutions GmbH Alfredstrasse 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 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 (704)450-9934 angela@blackwelldevice.com ## Device Description: Pre-sintered zirconia blanks for the fabrication of individual dental restorations. Copra Smile disks and blocks come in both white and pre-shaded in 0M1, 0M2, 0M3, A1-D4 and Joy Five-Nine in various sizes. Copra Supreme Hyperion disks and blocks come pre-shaded in 0M1, 0M2, 0M3, A1-D4 and Joy Five-Nine in various sizes. ## Indications for Use: Copra Smile consists of machinable zirconia discs and blocks for preparation of single crowns, bridges with maximum of one pontic between two crowns and inlays, onlays and veneers. Copra Supreme Hyperion 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 Copra Smile and Copra Supreme Hyperion were tested according to ISO 6872:2015 and all parameters meet the standard. {5}------------------------------------------------ A biocompatibility assessment of Copra Smile and Copra Supreme Hyperion was done in accordance with ISO 10993-1:2018. Mechanism of Action: Used in a milling machine for fabrication of a dental restoration Predicate Device: 3M Lava Esthetic K161922 Reference Devices: Ivoclar ZirCad MT K051705 ## 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 Smile white | Copra Smile OM1-<br>D4 Joy Five - Nine | 3M Lava Esthetic<br>Predicate Device | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510k Number | | | K161922 | | Common Name | Zirconia blanks | Zirconia blanks | Zirconia blanks | | Classification<br>Name | Porcelain powder<br>for clinical use | Porcelain powder<br>for clinical use | Porcelain<br>powder for<br>clinical use | | Class | II | II | II | | Product Code | EIH | EIH | EIH | | CFR | 872.6660 | 872.6660 | 872.6660 | | Indications for Use | Copra Smile<br>consists of<br>machinable<br>zirconia discs and<br>blocks for<br>preparation of<br>single crowns,<br>bridges with<br>maximum of one<br>pontic between<br>two crowns and<br>inlays, onlays and<br>veneers. | Copra Smile<br>consists of<br>machinable<br>zirconia discs and<br>blocks for<br>preparation of<br>single crowns,<br>bridges with<br>maximum of one<br>pontic between<br>two crowns and<br>inlays, onlays and<br>veneers. | Single crowns,<br>bridges with<br>maximum of one<br>pontic between<br>two crowns and<br>inlays, onlays<br>and veneers. | | Device Description | Pre-sintered<br>zirconia blanks for<br>the fabrication of<br>individual dental<br>restorations.<br><br>Copra Smile disks<br>and blocks come<br>in both white and | Pre-sintered<br>zirconia blanks for<br>the fabrication of<br>individual dental<br>restorations.<br><br>Copra Smile disks<br>and blocks come<br>in both white and | Lava Esthetic<br>zirconia blanks<br>are used for the<br>fabrication of<br>esthetic zirconia<br>restorations. The<br>blanks are<br>available in<br>various heights | | | pre-shaded in | pre-shaded in | and shades | | | 0M1, 0M2, 0M3, | 0M1, 0M2, 0M3, | based on the | | | A1-D4 and Joy | A1-D4 and Joy | Vita™ Classical | | | Five-Nine in | Five-Nine in | shade guide. | | | various sizes. | various sizes. | After sintering, | | | | | restorations | | | | | display a | | | | | gradient shading | | | | | and inherent | | | | | fluorescence. | | | | | The restorations | | | | | are designed | | | | | using dental CAD | | | | | software and the | | | | | data is converted | | | | | into milling | | | | | paths by CAM | | | | | software. The | | | | | blanks can be | | | | | processed in | | | | | milling units | | | | | suitable for pre- | | | | | sintered zirconia. | | | | | Milled | | | | | restorations | | | | | must be final | | | | | sintered in a | | | | | furnace suitable | | | | | for zirconia per | | | | | the cycle | | | | | designated for | | | | | Lava Esthetic. | | Basic Design | Discs and blocks | 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<br>restoration | | Materials | ISO 6872:2015<br>Type II Class 4 | ISO 6872:2015<br>Type II Class 4 | ISO 6872:2015<br>Type II Class 4 | | Formula | ZrO2 with others | ZrO2 with others | ZrO2 with others | | Crystal<br>Morphology | Tetragonal | Tetragonal | Tetragonal | | Material | 5Y-TZP | 5Y-TZP | 5Y-TZP | | Processing | Sintering at temperature > 1450°C | Sintering at temperature > 1450°C | Sintering at temperature > 1500°C | | Dimensions | various | various | various | | Single Use | Yes | Yes | Yes | | Color | White | Pre-shaded | White and Pre-shaded | | Sterility | Non-sterile | Non-sterile | Non-sterile | | Flexural Strength MPa | 600-800 | 600-800 | 800 | | Fracture Toughness MPa·m1/2 | 3.5 | 3.5 | 3-5 | Zirconia discs and blocks from Whitepeaks Dental Solutions {6}------------------------------------------------ {7}------------------------------------------------ | Name | Copra Supreme<br>Hyperion 0M1-D4<br>Joy Five - Nine | Ivoclar ZirCad MT<br>Reference Device | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510k Number | | K051705 | | Common Name | Zirconia blanks | Zirconia blanks | | Classification<br>Name | Porcelain powder<br>for clinical use | Porcelain powder<br>for clinical use | | Class | II | II | | Product Code | EIH | EIH | | CFR | 872.6660 | 872.6660 | | Indications for Use | Copra Supreme<br>Hyperion consists<br>of machinable<br>zirconia discs and<br>blocks for the<br>preparation of full<br>ceramic crowns,<br>onlays and 3- and<br>4-unit bridges and<br>inlay bridges<br>(anterior and<br>molar. | IPS e.max ZirCAD<br>consists of<br>machinable<br>zirconia blocks for<br>the preparation of<br>full<br>ceramic crowns,<br>onlays and 3- and<br>4-unit bridges and<br>inlay bridges<br>(anterior and<br>molar.) | | Device Description | Pre-sintered<br>zirconia blanks for<br>the fabrication of<br>individual dental<br>restorations.<br><br>Copra Supreme<br>Hyperion disks | IPS e.max ZirCAD<br>is the material of<br>choice for cases in<br>which high<br>mechanical<br>stability, thin<br>restoration walls<br>and natural- | | | and blocks come<br>pre-shaded in<br>0M1, 0M2, 0M3,<br>A1-D4 and Joy<br>Five-Nine in<br>various sizes. | looking<br>esthetics* are of<br>the<br>essence. Tooth<br>preserving and<br>natural-looking<br>restorations* with<br>considerably<br>reduced wall<br>thicknesses can<br>be created as the<br>material provides<br>high strength. | | Basic Design | Discs and blocks | Discs and blocks | | 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 | | Materials | ISO 6872:2015<br>Type II Class 5 | ISO 6872:2015<br>Type II Class 5 | | Formula | ZrO2 with others | ZrO2 with others | | Crystal<br>Morphology | Tetragonal | Tetragonal | | Material | 4-5Y-TZP | 4-5Y-TZP | | Processing | Sintering at<br>temperature ><br>1500°C | Sintering at<br>temperature ><br>1500°C | | Dimensions | various | various | | Single Use | Yes | Yes | | Color | Pre-shaded | Pre-shaded | | Sterility | Non-sterile | Non-sterile | | Flexural Strength<br>MPa | 600-1100 | 800 | | Fracture<br>Toughness<br>MPa·m1/2 | 3.5 | 3-5 | {8}------------------------------------------------ Conclusion: Copra Smile and Copra Supreme Hyperion 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. 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 size and shape do not change their substantial equivalence to the predicate devices.