Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental milling blank and its physical properties and testing, with no mention of AI or ML in the device description, intended use, or performance studies. The CAD/CAM system mentioned is a standard manufacturing process and does not inherently imply AI/ML.

Therapeutic

No.
The device is a material (zirconia milling blanks) used by dental technicians to construct custom-made dental restorations, not a device that directly interacts with the patient for therapeutic purposes.

Diagnostic

No

The device is described as custom-made all-ceramic restorations and zirconia milling blanks for producing dental restorations. Its intended use is for construction by dental technicians, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states that the device is "zirconia milling blanks" and describes physical properties and testing related to the material and manufactured dental restorations, indicating it is a physical product, not software.

IVD (In Vitro Diagnostic)

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 all-ceramic restorations for anterior and posterior locations. This is a manufacturing process for a medical device (dental restoration), not a diagnostic test performed on biological samples.
Device Description: The device is a zirconia milling blank used to produce dental restorations. It's a material used in the creation of a medical device, not a test kit or instrument for analyzing biological specimens.
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 (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.

The testing described focuses on the physical and chemical properties of the material itself (flexural strength, shade, translucency, etc.) to ensure it is suitable for its intended purpose as a dental restoration material. This is quality control and performance testing for a medical device material, not diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes

EIH

Device Description

BruxZir® Esthetic blanks are zirconia milling blanks used for the production of highly 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, bleach, and pre-shaded varieties 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 (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)

Design verification according to BruxZir® Esthetic 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
Visual Shade Evaluation
Color Consistency
Translucency
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

No clinical data is included in this submission.

The test samples were made using the standard manufacturing process and OC process for BruxZir® Esthetic to ensure that the test samples meet the following criteria for the finished device:

Flexural Strength must be greater than 800 MPa after sintering, as measured per ISO 6872:2015/Amd 1:2018, Type II Class 5.
Grade of "Pass" for Visual Shade Match for all shades.
Color consistency ΔE calculation needs to be less than 2.00 between samples measured.
Translucency of each formulation must be within 1 % of the equivalent BruxZir Anterior-16 shade at 700nm.
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 %/℃ per ISO 6872:2015/Amd 1:2018.
The solubility must be lower than 100 ug/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® Esthetic 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® Esthetic, and the predicate device, BruxZir® Esthetic (K213425), by verifying that the modified device met all the design specification requirements, and the design changes were implemented successfully without causing any unexpected issues.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Flexural Strength: >800 MPa
Coefficient of Thermal Expansion: 10-11 x 10-6 /°C
Chemical Solubility:

Regulation Number and Section

§ 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.

Summary

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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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

May 1, 2024

Prismatik Dentalcraft, Inc. So Hyun Park Regulatory Affairs Manager 2144 Michelson Drive Irvine, California 92612

Re: K240882

Trade/Device Name: BruxZir® Esthetic Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: March 29, 2024 Received: April 1, 2024

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" (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).

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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.

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 medical devices and radiation-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,

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

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

Submission Number (if known)

K240882

Device Name

BruxZir® Esthetic

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.

Type of Use (Select one or both, as applicable)

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."

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Image /page/4/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a black border. The inside of the triangle is filled with a gradient of colors, including pink, red, orange, yellow, green, blue, and purple. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font.

K240882 - 510(k) Summary

Date Prepared: March 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® Esthetic 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) #: K231425

Predicate Trade Name: BruxZir® Esthetic

Product Code: EIH

DEVICE DESCRIPTION SUMMARY (21 CFR 807.92(a)(4))

BruxZir® Esthetic blanks are zirconia milling blanks used for the production of highly 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, bleach, and pre-shaded varieties that can be easily adjusted to match the final shade.

INTENDED USE/INDICATIONS FOR USE (21 CFR 807.92(a)(5))

The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

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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 on the left side that is divided into sections of different colors, including pink, red, yellow, green, blue, and purple. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC.", in a sans-serif font.

INDICATIONS FOR USE COMPARISON (21 CFR 807.92(a)(5))

The subject device, BruxZir® Esthetic, has the same indications for use as the predicate device, BruxZir® Esthetic (K213425). Both devices are indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

TECHNOLOGICAL COMPARISON (21 CFR 807.92(a)(6))

The subject device, BruxZir® Esthetic, is substantially equivalent in technical characteristics to the predicate device, BruxZir® Esthetic (K213425) in terms of overall design principles, material, and performance.

The subject device, BruxZir® Esthetic, is similar in terms of overall design to the predicate device, BruxZir® Esthetic (K213425). The subject device, BruxZir® Esthetic, is offered in a milling blank and GL Single Unit design to be used for milling single-unit restorations. The predicate device, BruxZir® Esthetic (K213425), is offered in the same designs with the addition of the GL Bridge Block, which is designed to be used for milling bridges (restorations of three or more units). The fundamental principle of operation of the subject device, BruxZir® Esthetic, and the predicate device, BruxZir® Esthetic (K213425), 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 (slip casting) does not affect the mechanical properties of the final finished device.

The subject device, BruxZir® Esthetic, is similar in terms of material composition to the predicate device, BruxZir® Esthetic (K213425). The main ceramic component is composed of yttriastabilized 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® Esthetic, and the predicate device, BruxZir® Esthetic (K213425). Both the subject device and the predicate device have similar physical/mechanical and biocompatibility properties that met the requirements of ISO 6875:2015/Amd 1:2018 (Type II, Class 5) and ISO 10993. Any differences between the subject device and the predicate device do not raise any new concerns of safety and effectiveness.

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Image /page/6/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.

| Attributes | Subject Device
(K240882) | Predicate Device
(K213425) | Comparison | |
|----------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Design Characteristics | Device Name | BruxZir® Esthetic | BruxZir® Esthetic | Same |
| | Manufacturer | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | 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 |
| | 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 size and
thicknesses | Various size and
thicknesses | Similar; Different
sizes and
thicknesses 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
restorations are then
sintered at a high
temperature. No color
needs to be added
before sintering. The
final target shades are
achievable without
additional coloring
steps. | 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. No color
needs to be added
before sintering. The
final target shades are
achievable without
additional coloring
steps. | Same |
| Attributes | Subject Device
(K240882) | Predicate Device
(K213425) | Comparison | |
| Shade | A1, A2, A3, A3.5, A4,
B1, B2, B3, B4, C1,
C2, C3, C4, D2, D3,
D4, White, Bleach | A1, A2, A3, A3.5, A4,
B1, B2, B3, B4, C1,
C2, C3, C4, D2, D3,
D4, White, BL1, BL3 | Similar; Fewer
bleach 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, White, Bleach | A1, A2, A3, A3.5, A4,
B1, B2, B3, B4, C1,
C2, C3, C4, D2, D3,
D4, White, BL1, BL3 | Similar; Fewer
final target shades
are offered for the
subject device. | |
| Flexural
Strength | >800 MPa | >800 MPa | Same | |
| Coefficient of
Thermal
Expansion
(CTE/25-500°C) | 10-11 x 10-6 /°C | 10-11 x 10-6 /°C | Same | |
| Chemical
Solubility |