(19 days)
Not Found
No
The device description focuses on the material properties and manufacturing process of zirconia milling blanks, with no mention of AI/ML in the intended use, device description, or performance studies.
No.
The device is a raw material (zirconia milling blanks) used to construct custom dental restorations, not a device that directly provides therapy or treatment to a patient.
No
Explanation: The device is described as zirconia milling blanks used for the construction of custom-made all-ceramic restorations (dental crowns, bridges). Its intended use is to produce dental restorations, not to diagnose a disease or condition.
No
The device description clearly states that the device is "zirconia milling blanks used to produce highly esthetic zirconia dental restorations." This indicates a physical material, not software. The testing and performance studies also focus on the physical properties of the material (flexural strength, translucency, etc.). While the material is used in conjunction with a CAD/CAM system (which involves software), the device itself is the physical blank.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for dental technicians to construct custom-made dental restorations. This is a manufacturing process for a medical device that will be placed in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a material (zirconia milling blanks) used to create a physical restoration. It doesn't perform any diagnostic function.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The testing described focuses on the physical and chemical properties of the material and the resulting restoration, which is consistent with the testing required for a medical device intended for implantation or placement in the body.
N/A
Intended Use / Indications for Use
The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
Contraindication: This device is contraindicated for dental restorations greater than 3-units in length.
BruxZir® Radiant is intended to be used in fabrication of dental restorations for the purpose of restoring chewing function. The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior locations. This device is contraindicated for dental restorations greater than 3-units in length.
Product codes
EIH
Device Description
BruxZir® Radiant are zirconia milling blanks used to produce highly esthetic zirconia dental restorations. The high esthetics and high strength of BruxZir® Radiant 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® Radiant Blanks are available in 6 shades, Brite, White, 100, 200, 300, 400, that can be easily adjusted to match the final shade.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior location (referring to regions of the mouth for dental restorations)
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
The test samples were made using the standard manufacturing process and QC process for BruxZir® Radiant to ensure that the test samples meet the following criteria for the finished device:
- Flexural Strength must be greater than 500 MPa after sintering, as measured per ISO . 6872:2015/Amd 1:2018, Type II Class 4.
- . Translucency of each formulation must be higher than the values shown in the table below at 700nm.
- Shade White: >59
- Shade Brite: >65
- Shade 100: >57
- Shade 200: >57
- Shade 300: >57
- Shade 400: >57
- Grade of "Pass" for Visual Shade Match for all shades.
- Color consistency ΔE calculation needs to be less than 2.00 between samples measured.
- The Coefficient of Thermal Expansion must be between 10-11 x 10-9/Celsius and the standard deviation of CTE must be no greater than 0.5 x 10-9 Celsius per ISO 6872:2015/Amd 1:2018.
- The solubility must be lower than 100 µg/cm² per ISO 6872:2015/Amd 1:2018.
- The activity concentration of Uranium-238 must not exceed 1.0 Bq'g-1 per ISO 6872:2015/Amd 1:2018.
- BruxZir® Radiant must be biocompatible, safe, and non-toxic.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification according to BruxZir® Radiant Design Verification Protocol was conducted by Prismatik Dentalcraft, Inc. The tests conducted are listed below:
- . Flexural Strength according to ISO 6872:2015/Amd 1:2018
- Translucency
- Visual Shade Evaluation
- Color Consistency
- Coefficient of Thermal Expansion according to ISO 6872:2015/Amd 1:2018
- Chemical Solubility according to ISO 6872:2015/Amd 1:2018
- Radioactivity according to ISO 6872:2015/Amd 1:2018
- . Biocompatibility according to ISO 10993-1:2018 and ISO 10993-5:2009
No clinical data is included in this submission.
The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria according to the design specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 20, 2024
Prismatik Dentalcraft, Inc. Su Hyun Park Regulatory Affairs Manager 2144 Michelson Drive Irvine, California 92612
Re: K240574
Trade/Device Name: BruxZir® Radiant Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: February 19, 2024 Received: March 1, 2024
Dear Su Hyun Park:
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 (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 located 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
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
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
2
Indications for Use
Submission Number (if known)
Device Name
BruxZir® Radiant
Indications for Use (Describe)
The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
Contraindication: This device is contraindicated for dental restorations greater than 3-units in length.
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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Image /page/3/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangle with different colors. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." The text is in a sans-serif font and is blue.
510(k) Summary
Date Prepared: February 29, 2024
CONTACT DETAILS (21 CFR 807.92(a)(1))
Applicant Name: Prismatik Dentalcraft, Inc.
Applicant Address: 2144 Michelson Drive, Irvine, CA 92612, USA
Applicant Contact Telephone: 949-863-5479
Applicant Contact: So Hyun Park, Regulatory Affairs Manager, MS
Applicant Contact Email: so.park(@glidewelldental.com
DEVICE NAME (21 CFR 807.92(a)(2))
Device Trade Name: BruxZir® Radiant
Common Name: Zirconia milling block or dental CAD/CAM block
Classification Name: Porcelain powder for clinical use
Regulation Number: 872.6660
Regulatory Class: Class II
Product Code: EIH
LEGALLY MARKETED PREDICATE DEVICE (21 CFR 807.92(a)(3))
Predicate 510(k) #: K150872
Predicate Trade Name: BruxZir® Anterior
Product Code: EIH
DEVICE DESCRIPTION SUMMARY (21 CFR 807.92(a)(4))
BruxZir® Radiant are zirconia milling blanks used to produce highly esthetic zirconia dental restorations. The high esthetics and high strength of BruxZir® Radiant 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® Radiant Blanks are available in 6 shades, Brite, White, 100, 200, 300, 400, that can be easily adjusted to match the final shade.
4
Image /page/4/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into sections of different colors, including pink, blue, and yellow. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
INTENDED USE/INDICATIONS FOR USE (21 CFR 807.92(a)(5))
BruxZir® Radiant is intended to be used in fabrication of dental restorations for the purpose of restoring chewing function. The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior locations.
This device is contraindicated for dental restorations greater than 3-units in length.
INDICATIONS FOR USE COMPARISON (21 CFR 807.92(a)(5))
The subject device, BruxZir® Radiant, has the same indications for use as the predicate device, BruxZir® Anterior (K150872). Both devices are indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior locations. Both the subject device, BruxZir® Radiant, and predicate device, BruxZir® Anterior (K150872), are also contraindicated for dental restorations greater than 3-units in length.
TECHNOLOGICAL COMPARISON (21 CFR 807.92(a)(6))
The subject device, BruxZir® Radiant, is substantially equivalent in technical characteristics to the predicate device, BruxZir® Anterior (K150872) in terms of overall design principles, material, and performance.
The subject device, BruxZir® Radiant, is similar in terms of overall design to the predicate device, BruxZir® Anterior (K150872). The subject device, BruxZir® Radiant, is only offered in one style (Zeno) milling blank whereas the predicate device, BruxZir® Anterior (K150872), is offered in various designs. There is no change in packaging for a milling blank. The fundamental principle of operation of the subject device, BruxZir® Radiant, and the predicate device, BruxZir® Anterior (K150872), is the same. 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. Although no color needs to be added additionally, pre-coloring before sintering and/or basic staining and glazing techniques may be used after sintering to achieve the desired shade. Also, the change in the manufacturing process from the press process to the colloidal process does not affect the mechanical properties of the final finished device.
The subject device, BruxZir® Radiant, is similar in terms of material composition to the predicate device, BruxZir® Anterior (K150872). The main ceramic component is composed of yttria-stabilized zirconia with varying trace amount of colorants. As the generic type of material has not changed, it does not alter the performance specifications of the subject device. The slight differences in overall chemical composition do not affect the biocompatibility and performance characteristics.
The technological comparison table below outlines and provides the similarities between the subject device, BruxZir® Radiant, and the predicate device, BruxZir® Anterior (K150872). Both the subject device and the predicate device have similar physical/mechanical and biocompatibility properties that met the requirements of ISO 6872:2015/Amd 1:2018 (Type
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Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
II, Class 4) and ISO 10993. Any differences between the subject device and the predicate device do not raise any new concerns of safety and effectiveness.
| Attributes | | Subject Device
(TBD) | Predicate Device
(K150872) | Comparison |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name
Manufacturer | | BruxZir® Radiant
Prismatik Dentalcraft, Inc. | BruxZir® Anterior
Prismatik Dentalcraft, Inc. | N/A
Same |
| Product Code | | EIH | EIH | Same |
| Prescription Device | | Yes | Yes | Same |
| Indications for Use | | The device is indicated
for use by dental
technicians in the
construction of custom
made all ceramic
restorations for anterior
and posterior location. | The device is indicated
for use by dental
technicians in the
construction of custom
made all ceramic
restorations for anterior
and posterior location. | Same |
| Contraindications | | This device is
contraindicated for
dental restorations
greater than 3-units in
length. | This device is
contraindicated for
dental restorations
greater than 3-units in
length. | Same |
| Design
Characteristic | Chemical
Composition | The main ceramic
component is
composed of yttria-
stabilized zirconia. The
different shades have
varying trace colorants
as required to match
the desired shades. | The main ceramic
component is
composed of yttria-
stabilized zirconia.
The different shades
have varying trace
colorants as required
to match the desired
shades. | Similar; Different
yttria proportion of the
main ceramic
components and
different oxide
colorants for the
subject device. |
| | Design | Various sizes and
thicknesses | Various sizes and
thicknesses | Similar; Different
sizes and thicknesses
are offered for the
subject device. |
| | Principle of
Operation | The manufactured
dental restorations are
made utilizing a
CAD/CAM system for
design and
manufacture. The
designed and
manufactured dental | The manufactured
dental restorations are
made utilizing a
CAD/CAM system for
design and
manufacture. The
designed and
manufactured dental | Same |
| Attributes | Subject Device
(TBD) | Predicate Device
(K150872) | Comparison | |
| Shades | sintered at a high
temperature. The final
target shades can be
easily adjusted to
match the final shade.
Brite, White, 100, 200,
300, 400 | sintered at a high
temperature. The final
target shades can be
easily adjusted to
match the final shade.
White, 150, 250, 350,
450, 550 | Different; different
shades are offered for
the subject device. | |
| Final Vita
Shades | A1, A2, A3, A3.5, A4,
B1, B2, B3, B4, C1,
C2, C3, C4, D2, D3,
D4 | A1, A2, A3, A3.5, A4,
B1, B2, B3, B4, C1,
C2, C3, C4, D2, D3,
D4 | Same | |
| Flexural Strength | >500 MPa | >500 MPa | Same | |
| Coefficient of
Thermal
Expansion
(CTE/25-500°C) | 10-11x10-6/°C | 10-11x10-6/°C | Same | |
| Chemical
Solubility | 59 |
| Brite | >65 |
| 100 | >57 |
| 200 | >57 |
| 300 | >57 |
| 400 | >57 |
- Grade of "Pass" for Visual Shade Match for all shades. ●
- Color consistency ΔE calculation needs to be less than 2.00 between samples measured.
- The Coefficient of Thermal Expansion must be between 10-11 x 10-9/℃ and the standard deviation of CTE must be no greater than 0.5 x 10-9℃ per ISO 6872:2015/Amd 1:2018.
- The solubility must be lower than 100 µg/cm² per ISO 6872:2015/Amd 1:2018. ●
- The activity concentration of Uranium-238 must not exceed 1.0 Bq'g-1 per ISO ● 6872:2015/Amd 1:2018.
- BruxZir® Radiant must be biocompatible, safe, and non-toxic.
The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria according to the design specifications. The results of the testing were used to address questions related to substantial equivalence based on differences in technological features between the subject device. BruxZir® Radiant, and the predicate device, BruxZir® Anterior (K150872), by verifying that the modified device met all the design specification requirements, and the design changes were implemented successfully without causing any unexpected issues.