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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the medical device BruxZir® Radiant. It outlines the acceptance criteria and the studies conducted to demonstrate that the device meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Flexural Strength: >500 MPa per ISO 6872:2015/Amd 1:2018 (Type II Class 4)	The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, including Flexural Strength >500 MPa.
Translucency at 700nm:	The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, indicating that the translucency of each formulation was higher than the specified values:
* White: >59%	* White: >59%
* Brite: >65%	* Brite: >65%
* 100: >57%	* 100: >57%
* 200: >57%	* 200: >57%
* 300: >57%	* 300: >57%
* 400: >57%	* 400: >57%
Visual Shade Match: Grade of "Pass" for all shades	The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, implying a "Pass" grade for Visual Shade Match for all shades.
Color Consistency: ΔE < 2.00 between samples measured	The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, meaning Color consistency ΔE was less than 2.00 between samples measured.
Coefficient of Thermal Expansion (CTE): 10-11 x 10^-6/^℃ and standard deviation of CTE no greater than 0.5 x 10^-6/^℃ per ISO 6872:2015/Amd 1:2018	The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, indicating CTE was between 10-11 x 10^-6/^℃ and its standard deviation was no greater than 0.5 x 10^-6/^℃.
Chemical Solubility: <100 µg/cm² per ISO 6872:2015/Amd 1:2018	The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, showing solubility was lower than 100 µg/cm².
Radioactivity: Activity concentration of Uranium-238 no more than 1.0 Bq/g per ISO 6872:2015/Amd 1:2018	The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, indicating the activity concentration of Uranium-238 did not exceed 1.0 Bq/g.
Biocompatibility: Biocompatible, safe, and non-toxic	The results of the verification activities confirmed that the design of the subject device met all the predetermined criteria, meaning BruxZir® Radiant is biocompatible, safe, and non-toxic. This was evaluated according to ISO 10993-1:2018 and ISO 10993-5:2009.

2. Sample size used for the test set and the data provenance

The document states that "The test samples were made using the standard manufacturing process and QC process for BruxZir® Radiant." It does not specify the exact sample size for each test. The data provenance is internal, originating from Prismatik Dentalcraft, Inc., and appears to be from prospective testing of manufactured samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts or the establishment of ground truth by experts for the test set. The tests performed are primarily laboratory-based physical, chemical, and biological evaluations according to ISO standards. For "Visual Shade Evaluation," it simply states a "Grade of 'Pass'," without detailing the evaluators or their qualifications.

4. Adjudication method for the test set

The document does not describe any adjudication method as the tests are primarily objective measurements against established international standards.

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

No MRMC comparative effectiveness study was done, and this device is a dental material (zirconia milling blank), not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone algorithm performance study was done as this is not an AI/algorithm-based device.

7. The type of ground truth used

The ground truth for the performance criteria is established by international standards (ISO 6872:2015/Amd 1:2018, ISO 10993-1:2018, and ISO 10993-5:2009). These standards define the acceptable ranges and methodologies for evaluating dental ceramics.

8. The sample size for the training set

No training set is applicable as this is not an AI/machine learning device. The device's performance is based on its material properties, not on an algorithm trained on data.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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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.

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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

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Indications for Use

Submission Number (if known)

K240574

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))

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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 NameManufacturer		BruxZir® RadiantPrismatik Dentalcraft, Inc.	BruxZir® AnteriorPrismatik Dentalcraft, Inc.	N/ASame
Product Code		EIH	EIH	Same
Prescription Device		Yes	Yes	Same
Indications for Use		The device is indicatedfor use by dentaltechnicians in theconstruction of custommade all ceramicrestorations for anteriorand posterior location.	The device is indicatedfor use by dentaltechnicians in theconstruction of custommade all ceramicrestorations for anteriorand posterior location.	Same
Contraindications		This device iscontraindicated fordental restorationsgreater than 3-units inlength.	This device iscontraindicated fordental restorationsgreater than 3-units inlength.	Same
DesignCharacteristic	ChemicalComposition	The main ceramiccomponent iscomposed of yttria-stabilized zirconia. Thedifferent shades havevarying trace colorantsas required to matchthe desired shades.	The main ceramiccomponent iscomposed of yttria-stabilized zirconia.The different shadeshave varying tracecolorants as requiredto match the desiredshades.	Similar; Differentyttria proportion of themain ceramiccomponents anddifferent oxidecolorants for thesubject device.
	Design	Various sizes andthicknesses	Various sizes andthicknesses	Similar; Differentsizes and thicknessesare offered for thesubject device.
	Principle ofOperation	The manufactureddental restorations aremade utilizing aCAD/CAM system fordesign andmanufacture. Thedesigned andmanufactured dental	The manufactureddental restorations aremade utilizing aCAD/CAM system fordesign andmanufacture. Thedesigned andmanufactured dental	Same
Attributes	Subject Device(TBD)	Predicate Device(K150872)	Comparison
Shades	sintered at a hightemperature. The finaltarget shades can beeasily adjusted tomatch the final shade.Brite, White, 100, 200,300, 400	sintered at a hightemperature. The finaltarget shades can beeasily adjusted tomatch the final shade.White, 150, 250, 350,450, 550	Different; differentshades are offered forthe subject device.
Final VitaShades	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 ofThermalExpansion(CTE/25-500°C)	10-11x10-6/°C	10-11x10-6/°C	Same
ChemicalSolubility	<100 µg/cm²	<100 µg/cm²	Same
Radioactivity	The activityconcentration ofUranium-238 is nomore than 1.0 Bq/g.	The activityconcentration ofUranium-238 is nomore than 1.0 Bq/g.	Same
Biocompatibility	Biocompatible andnon-toxic	Biocompatible andnon-toxic	Same
Sterility	Non-sterile	Non-sterile	Same
ManufacturingProcess	Colloidal Process	Biaxial PressingProcess	Differentmanufacturing process

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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.

NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY & CONCLUSIONS 21 CFR 807.92(b))

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

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Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle with a color gradient on the left and the company name on the right. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

No clinical data is included in this submission.

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	BruxZir® Radiant % Translucency at 700nm
White	>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.

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.