(29 days)
Not Found
No
The summary describes a dental restoration material and its physical properties, with no mention of AI or ML technology.
No.
The device is a material used for the construction of dental restorations, which are prosthetic devices, not therapeutic devices. Therapeutic devices are typically used to treat a disease or condition, which this material does not.
No
This device is a material used for constructing dental restorations, not for diagnosing medical conditions. The performance studies focus on material properties (flexural strength, solubility, etc.) and biocompatibility, not diagnostic performance metrics.
No
The device description and performance studies clearly indicate that this is a physical material (zirconia blocks) used for dental restorations, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating dental restorations, which are physical devices placed in the mouth.
- Device Description: The device is a material (zirconia blocks) used to construct these restorations.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens derived from the human body. IVDs are typically used for testing blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening.
The information provided clearly describes a material used in the manufacturing of a medical device (dental restorations), not a diagnostic test.
N/A
Intended Use / Indications for Use
BruxZir® Esthetic NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
Product codes
EIH
Device Description
BruxZir® Esthetic NOW is a chairside zirconia material offering enhanced esthetic performance. These pre-shaded, fully sintered zirconia CAD/CAM blocks are used by dentists in the construction of custom-made dental restorations that require no sintering, staining, glazing or polishing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental laboratories or by dental professionals.
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)
Non-clinical data submitted to demonstrate substantial equivalence include:
- Flexural Strength according to ISO 6872:2024
- Chemical Solubility according to ISO 6872:2024
- Coefficient of Thermal Expansion (CTE) according to ISO 6872:2024
- Shade evaluation
- Biocompatibility according to ISO 10993-1:2018
- Radioactivity according to ISO 6872:2024
- Packaging Validation according to ASTM D4169-22
Flexural Strength: Flexural strength was tested on the worst-case shades and additional shade for BruxZir® Esthetic NOW. The average flexural strength of each worst-case yielded the results above the minimum threshold of 800 MPa, which is the value to be achieved for Type II Class 5 ceramic product according to ISO 6872:2024.
Chemical Solubility: The worst cases of BruxZir® Esthetic NOW were tested for solubility and the measured values were 800 MPa
Chemical Solubility:
§ 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
February 25, 2025
Image /page/0/Picture/1 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 acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name.
Prismatik Dentalcraft, Inc. So Hyun Park Regulatory Affairs Manager 2144 Michelson Drive Irvine, California 92612
Re: K250223
Trade/Device Name: BruxZir® Esthetic NOW Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: January 24, 2025 Received: January 27, 2025
Dear So 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 (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).
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Sincerely,
Bobak Shirmohamma di -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
Indications for Use
Submission Number (if known)
Device Name
BruxZir® Esthetic NOW
Indications for Use (Describe)
BruxZir® Esthetic NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
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/4/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangle with a black border. The inside of the triangle is filled with a gradient of colors, including pink, red, yellow, green, blue, and purple. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font.
K250223
510(k) Summary
I. SUBMITTER
Prismatik Dentalcraft, Inc. 2144 Michelson Drive, Irvine, CA 92612, USA
Primary Contact Person: So Hyun Park, Regulatory Affairs Manager Email: so.park(@glidewelldental.com Phone: (949) 863-5479
Secondary Contact Person: Maria Wagner, Sr, Regulatory Affairs Manager Email: maria.wagner@glidewelldental.com Phone: (949) 838-1321
Date Prepared: January 24, 2025
II. DEVICE
| Name of Device: | BruxZir® Esthetic NOW |
|---|---|
| Common Name or Usual Name: | Zirconia Milling Block or Dental CAD/CAM Block |
| Classification Name: | Porcelain powder for clinical use |
| (21 CFR 872.6660) | |
| Regulatory Class: | Class II |
| Product Code: | EIH |
III. PREDICATE DEVICE
BruxZir® NOW (K220816)
IV. DEVICE DESCRIPTION
BruxZir® Esthetic NOW is a chairside zirconia material offering enhanced esthetic performance. These pre-shaded, fully sintered zirconia CAD/CAM blocks are used by dentists in the construction of custom-made dental restorations that require no sintering, staining, glazing or polishing.
INDICATIONS FOR USE V.
BruxZir® Esthetic NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
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Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle with a gradient of colors on the left side. The text "PRISMATIK DENTALCRAFT, INC." is on the right side of the triangle. The text is in a sans-serif font and is blue.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Technological
Characteristics | Subject Device
(K250223) | Predicate Device
(K220816) | Comparison | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Device Name | BruxZir® Esthetic NOW | BruxZir® NOW | N/A | |
| Manufacturer | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | Same | |
| Product Code | EIH | EIH | Same | |
| Prescription Device | Yes | Yes | Same | |
| Intended Use | BruxZir® Esthetic NOW
is intended to be used in
fabrication of dental
restorations such as
crowns for the purpose
of restoring chewing
function. | BruxZir® NOW is
intended to be used in
fabrication of dental
restorations such as
crowns and bridges for
the purpose of restoring
chewing function. | Similar; Due to the
device design, the
subject device can
only be fabricated into
a single-unit
restoration. | |
| Indications for Use | BruxZir® Esthetic NOW
is used for dental
restorations using
different CAD/CAM or
manual milling
machines. All blocks are
processed through dental
laboratories or by dental
professionals. | BruxZir® NOW is used
for dental restorations
using different
CAD/CAM or manual
milling machines. All
blocks are processed
through dental
laboratories or by dental
professionals. | Same except for the
device trade name | |
| Material
Composition | The device is composed
of Yttria-stabilized
zirconia (YSZ) and
pigments to achieve the
desired shades. | The device is composed
of Yttria-stabilized
zirconia (YSZ) and
pigments to achieve the
desired shades. | Similar; Both the
subject device and the
predicate device are
composed of Yttria-
stabilized zirconia as
the primary
component and the
desired shades are
achieved by using
different pigments. | |
| Design
Characteristics | Fully sintered zirconia
block available in block
form in 2 sizes for
single-unit restoration
(anterior and posterior
geometries) | Fully sintered zirconia
block available in block
form in 2 sizes for single
and multiple-unit
restorations | Similar; Due to the
device design, the
subject device can
only be fabricated into
a single-unit
restoration. | |
| Shades | BruxZir® Esthetic NOW
is available in the
following shades: Bleach
White, Bleach 1 and 16 | BruxZir® NOW is
available in the
following shades:
Bleach White, Bleach 1 | Similar; The subject
device and the
predicate device are
offered in Bleach | |
| Technological
Characteristics | | Subject Device
(TBD) | Predicate Device
(K220816) | Comparison |
| | | VITA Classical Shades
(A1, A2, A3, A3.5, A4,
B1, B2, B3, B4, C1, C2,
C3, C4, D2, D3, D4) | Bleach 3, and 16 VITA
Classical shades (A1,
A2, A3, A3.5, A4, B1,
B2, B3, B4, C1, C2, C3,
C4, D2, D3, D4).
BruxZir® NOW Bridge
Block is available in the
following 6 VITA
Classical shades: A1, | shades and 16 VITA
Classical shades. The
subject device is not
offered in Bleach 3
shade. |
| | | | A2, A3, B1, C2, D2. | |
| | Flexural
Strength | >800 MPa
Type II Class 5 per ISO
6872:2024 | >800 MPa Type II Class
5 per ISO
6872:2015/Amd 1:2018 | Same |
| | Biocompatibility | Biocompatible per
ISO 10993-1 | Biocompatible per
ISO 10993-1 | Same |
| | Solubility |