(358 days)
No
The summary describes a material (zirconia blanks) used for fabricating dental restorations, with performance studies focused on physical and biocompatibility properties. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is a material (zirconia blanks) used by dental technicians to construct custom-made all-ceramic dental restorations. It does not directly treat or prevent a disease or condition in a patient; rather, it is a component of a restorative dental device.
No
This device is a material (zirconia blanks) used by dental technicians to construct dental restorations. It does not diagnose any condition or disease.
No
The device is described as "Pre-sintered zirconia blanks" which are physical materials used in dental restorations, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the construction of custom-made all-ceramic dental restorations. This is a device used in the mouth for structural purposes, not for testing samples outside the body to diagnose or monitor a medical condition.
- Device Description: The device is described as pre-sintered zirconia blanks for fabricating dental restorations. This aligns with a dental prosthetic material, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a patient's health status
- Use in a laboratory setting for testing
The information provided clearly indicates a dental material used for creating physical restorations, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / 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.
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. Copra Supreme disks come in both white and pre-shaded 0M1-D4 in various sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior location (dental)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental technicians
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Flexural Strength MPa: 1100
- Fracture Toughness MPa·m1/2: 3.5
- Solubility µg/cm²: 6.8 (for white), 6.6-6.8 (for 0M1-D4)
- Radioactivity:
§ 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.
0
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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"
1
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
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
3
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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4
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: 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 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
5
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
6
| | | | having a premolar
width
Inlays, Onlays,
Veneers | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. | Pre-sintered
zirconia blanks for
the fabrication of
individual dental
restorations. | BruxZir®
Esthetic blanks
are zirconia
milling blanks
used for the
production of
esthetic
zirconia dental
restorations.
The high
esthetics and
high strength of
BruxZir®
Esthetic
restorations
make them
viable for use in
all regions of
the mouth. The
manufactured
dental
restorations are
made utilizing a
CAD/CAM
system for
design
and
manufacture.
The designed
and
manufactured
dental
restorations are
then sintered
at a high
temperature.
BruxZir®
Esthetic blanks
are available in
white and pre-
shaded |
| | | | | varieties that
can be easily
adjusted to
match the final
shade. |
| Basic Design | Discs | Discs | Discs and blocks | Discs |
| 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 a
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 | 4Y-TZP | 4Y-TZP | 3Y-TZP | 4Y-TZP |
| Processing | Sintering at
temperature >
1450°C | Sintering at
temperature >
1450°C | Sintering at
temperature >
1450°C | Sintering at
temperature >
1450°C |
| Dimensions | various | various | various | various |
| Single Use | Yes | Yes | Yes | Yes |
| Color | White | Pre-shaded | White | White and Pre-
shaded |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Flexural Strength
MPa | 1100 | 1100 | 1400 | 980 |
| Fracture
Toughness
MPa·m1/2 | 3.5 | 3.5 | 5 | 2.7-3.1 |
| Solubility µg/cm² | 6.8 | 6.6-6.8 | 6.7 |