(267 days)
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).
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.
The provided text describes a 510(k) premarket notification for dental zirconia blanks and does not contain information about a study proving the device meets acceptance criteria as typically found for AI/ML-enabled medical devices. The device in question, Copra Smile and Copra Supreme Hyperion, are "Porcelain Powder For Clinical Use" (Class II, Product Code: EIH), which are physical materials, not software or AI/ML components.
The "Testing Summary" in the document states:
"The physical properties of Copra Smile and Copra Supreme Hyperion were tested according to ISO 6872:2015 and all parameters meet the standard. A biocompatibility assessment of Copra Smile and Copra Supreme Hyperion was done in accordance with ISO 10993-1:2018."
This indicates that the acceptance criteria are adherence to the ISO 6872:2015 standard for physical properties of dental ceramics and ISO 10993-1:2018 for biocompatibility.
Here's the information, structured as requested, based on the provided text, with clarifications where details are not present for an AI/ML context:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criterion (Standard) | Device Performance (Copra Smile) | Device Performance (Copra Supreme Hyperion) | Predicate Device (3M Lava Esthetic) | Reference Device (Ivoclar ZirCad MT) |
|---|---|---|---|---|
| ISO 6872:2015 for Physical Properties | All parameters meet the standard | All parameters meet the standard | Meets ISO 6872:2015 | Meets ISO 6872:2015 |
| Type of Material (ISO 6872:2015) | Type II Class 4 | Type II Class 5 | Type II Class 4 | Type II Class 5 |
| Flexural Strength (MPa) | 600-800 | 600-1100 | 800 | 800 |
| Fracture Toughness (MPa·m1/2) | 3.5 | 3.5 | 3-5 | 3-5 |
| ISO 10993-1:2018 for Biocompatibility | Assessment done in accordance with standard | Assessment done in accordance with standard | Not explicitly stated but assumed for a legally marketed device | Not explicitly stated but assumed for a legally marketed device |
Note: The detailed acceptance values within ISO 6872:2015 for "all parameters" are not explicitly listed in the document beyond Flexural Strength and Fracture Toughness. The document states that the physical properties of the subject devices, predicate, and reference devices all meet ISO 6872:2015.
2. Sample sized used for the test set and the data provenance
- Sample Size: The document does not specify the sample size for the physical properties and biocompatibility testing. This would typically be detailed in the test reports, which are summarized here.
- Data Provenance: Not explicitly stated, but the testing would typically be performed by the manufacturer or a contracted lab to generate data for submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as this is not an AI/ML device requiring expert ground truth in the traditional sense. The "ground truth" here is established by the physical and chemical properties of the material and its biological interaction determined through standardized tests, rather than expert interpretation of images or other data.
4. Adjudication method for the test set
Not applicable as this is not an AI/ML device requiring adjudication of expert interpretations. The tests for physical properties and biocompatibility are objective, standardized measurements.
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
Not applicable. This is a physical dental material, not an AI-assisted diagnostic tool or software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical dental material, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device (Copra Smile and Copra Supreme Hyperion) is established by:
- Standardized Physical Property Measurements: Adherence to the specifications outlined in ISO 6872:2015 for dental ceramic materials (e.g., specific values for flexural strength, fracture toughness, chemical composition, microstructure).
- Biocompatibility Testing: Results from tests conducted according to ISO 10993-1:2018 to evaluate the biological response to the material.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set. The "training" in manufacturing would relate to process control and material formulation development, not data-driven model training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model. The formulation and manufacturing parameters for the dental blanks would be established through material science research, development, and quality control processes to ensure the desired physical and chemical properties are achieved consistently.
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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.
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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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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)
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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.
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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-D4 Joy Five - Nine | 3M Lava EstheticPredicate Device |
|---|---|---|---|
| 510k Number | K161922 | ||
| Common Name | Zirconia blanks | Zirconia blanks | Zirconia blanks |
| ClassificationName | Porcelain powderfor clinical use | Porcelain powderfor clinical use | Porcelainpowder forclinical use |
| Class | II | II | II |
| Product Code | EIH | EIH | EIH |
| CFR | 872.6660 | 872.6660 | 872.6660 |
| Indications for Use | Copra Smileconsists ofmachinablezirconia discs andblocks forpreparation ofsingle crowns,bridges withmaximum of onepontic betweentwo crowns andinlays, onlays andveneers. | Copra Smileconsists ofmachinablezirconia discs andblocks forpreparation ofsingle crowns,bridges withmaximum of onepontic betweentwo crowns andinlays, onlays andveneers. | Single crowns,bridges withmaximum of onepontic betweentwo crowns andinlays, onlaysand veneers. |
| Device Description | Pre-sinteredzirconia blanks forthe fabrication ofindividual dentalrestorations.Copra Smile disksand blocks comein both white and | Pre-sinteredzirconia blanks forthe fabrication ofindividual dentalrestorations.Copra Smile disksand blocks comein both white and | Lava Estheticzirconia blanksare used for thefabrication ofesthetic zirconiarestorations. Theblanks areavailable invarious 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 ofAction | 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 4 | ISO 6872:2015Type II Class 4 | ISO 6872:2015Type II Class 4 |
| Formula | ZrO2 with others | ZrO2 with others | ZrO2 with others |
| CrystalMorphology | 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
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| Name | Copra SupremeHyperion 0M1-D4Joy Five - Nine | Ivoclar ZirCad MTReference Device |
|---|---|---|
| 510k Number | K051705 | |
| Common Name | Zirconia blanks | Zirconia blanks |
| ClassificationName | Porcelain powderfor clinical use | Porcelain powderfor clinical use |
| Class | II | II |
| Product Code | EIH | EIH |
| CFR | 872.6660 | 872.6660 |
| Indications for Use | Copra SupremeHyperion consistsof machinablezirconia discs andblocks for thepreparation of fullceramic crowns,onlays and 3- and4-unit bridges andinlay bridges(anterior andmolar. | IPS e.max ZirCADconsists ofmachinablezirconia blocks forthe preparation offullceramic crowns,onlays and 3- and4-unit bridges andinlay bridges(anterior andmolar.) |
| Device Description | Pre-sinteredzirconia blanks forthe fabrication ofindividual dentalrestorations.Copra SupremeHyperion disks | IPS e.max ZirCADis the material ofchoice for cases inwhich highmechanicalstability, thinrestoration wallsand natural- |
| and blocks comepre-shaded in0M1, 0M2, 0M3,A1-D4 and JoyFive-Nine invarious sizes. | lookingesthetics* are oftheessence. Toothpreserving andnatural-lookingrestorations* withconsiderablyreduced wallthicknesses canbe created as thematerial provideshigh strength. | |
| Basic Design | Discs and blocks | Discs and blocks |
| Mechanism ofAction | Used in a millingmachine forfabrication of adental restoration | Used in a millingmachine forfabrication of adental restoration |
| Materials | ISO 6872:2015Type II Class 5 | ISO 6872:2015Type II Class 5 |
| Formula | ZrO2 with others | ZrO2 with others |
| CrystalMorphology | Tetragonal | Tetragonal |
| Material | 4-5Y-TZP | 4-5Y-TZP |
| Processing | Sintering attemperature >1500°C | Sintering attemperature >1500°C |
| Dimensions | various | various |
| Single Use | Yes | Yes |
| Color | Pre-shaded | Pre-shaded |
| Sterility | Non-sterile | Non-sterile |
| Flexural StrengthMPa | 600-1100 | 800 |
| FractureToughnessMPa·m1/2 | 3.5 | 3-5 |
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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.
§ 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.