BruxZirTM TintEFX Coloring Liquid comprises a set of solutions that enhance the esthetic properties of zirconia restorations. The solution is applied to the zirconia restorations before sintering, by dipping the framework into the liquid or by using a metal-free brush. Afterwards, the structure is dried and subsequently sintered at temperatures above 1400°C.

BruxZir™ TintEFX Coloring Liquid is available in 14 different colors, Brown, Green, Blue, Pink, Orange, Purple, Grey, Yellow, G00, G0, G1, G3, G4, and G5. The devices can be used on the gingival part, body part, and/or incisal part of dental restoration to provide esthetic properties and mimic nature tooth color. The devices are intended to be used solely by dental technicians for fabrication of zirconia restorations for individual dental patients.

AI/ML Overview

This document describes the FDA's 510(k) clearance for BruxZir™ TintEFX Coloring Liquid, a dental product. It primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria for an AI/CADe medical device study. Therefore, most of the information requested in your prompt (e.g., sample size for test set, number of experts, MRMC studies, training set details) is not applicable to this type of submission.

This document is for a "Porcelain Powder For Clinical Use" (though the device itself is a liquid for coloring zirconia) which falls under a general controls classification. The "performance data" presented are non-clinical tests to show the new device performs similarly to the predicate and meets general dental material standards.

However, I can extract the information that is present and explain why other aspects are not applicable.

Explanation of Non-Applicability:

The requested information (e.g., sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, ground truth establishment for training) is highly relevant for the assessment of AI/CADe (Computer-Assisted Detection/Diagnosis) medical devices or other diagnostic/interpretive devices where the primary function is to analyze data (like medical images) and provide an output that impacts a clinical decision.

This document describes a coloring liquid used in the fabrication of dental restorations. Its performance is evaluated based on material properties (flexural strength, chemical solubility, visual shade) and biocompatibility, not on its ability to "diagnose" or "detect" anything using an algorithm. Therefore, the concepts of "test set," "training set," "ground truth experts," or "AI assistance" do not apply.

Here's the breakdown of the available information, addressing your points where applicable:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in the format of a diagnostic performance study (e.g., sensitivity, specificity thresholds). Instead, it refers to industry standards and general material requirements. The "performance" is reported as meeting these standards.

Acceptance Criteria/Standard	Reported Device Performance
Material Properties:
Flexural Strength (>800 MPa for predicate)	>800 MPa (Meets ISO 6872:2015/Amd 1:2018 for Type II, Class 5)
Chemical Solubility (<100 µg/cm² for predicate)	<100 µg/cm² (Meets ISO 6872:2015/Amd 1:2018 requirement)
Functional Properties:
Visual Shade Evaluation (Pass for predicate)	Pass (Meets shade match requirements and works as intended)
Shelf Life:
Accelerated aging test per ASTM F1980-21	0.5 years shelf life established
Biocompatibility:
ISO 10993-1 requirements	Tested for Cytotoxicity (ISO 10993-5:2009), Skin Sensitization (ISO 10993-10:2021), and Oral Mucosal Irritation (ISO 10993-10:2021). No biocompatibility concern.
Packaging:
Suitable to withstand distribution	Uses same packaging materials and configurations as predicate; previous validation used to support.

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

Sample Size: Not specified in terms of a "test set" for diagnostic performance. For material testing, typical sample sizes are implied by the ISO standards (e.g., a certain number of specimens for flexural strength), but exact numbers are not provided in this summary.
Data Provenance: Not applicable. This is a non-clinical evaluation of a material, not a study involving patient data.

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

Not applicable. There is no "ground truth" establishment by experts in the sense of reviewing clinical cases or images. For "Visual Shade Evaluation," it states "performed on the sintered and glazed restorations by qualified reviewers against reference shade guides." The number and specific qualifications of these "qualified reviewers" are not detailed, as this is a quality control/aesthetic assessment, not a clinical diagnostic assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This relates to obtaining a consensus truth for diagnostic studies, which is not relevant here.

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

Not applicable. This type of study evaluates human reader performance with and without AI, which is not relevant for a dental coloring liquid.

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

Not applicable. There is no algorithm being evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the conventional sense. The "ground truth" for this device's performance is adherence to established material standards (like ISO 6872:2015) for physical properties and subjective assessment against shade guides for visual properties. Biocompatibility relies on adherence to ISO 10993 standards and testing results.

8. The sample size for the training set

Not applicable. No AI algorithm requiring a training set is involved.

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

Not applicable. No AI algorithm requiring a training set is involved.

In summary, this FDA clearance document for BruxZir™ TintEFX Coloring Liquid pertains to a dental material, not an AI or diagnostic device. As such, the typical acceptance criteria and study methodologies relevant to AI/CADe are not found or applicable in this submission. The "study" mentioned here refers to non-clinical laboratory testing to prove the material meets relevant standards and is substantially equivalent to a predicate 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.

June 9, 2023

Prismatik Dentalcraft, Inc. Nina Chiang Regulatory Affairs Specialist 2144 Michelson Drive Irvine, California 92612

Re: K231347

Trade/Device Name: BruxZir™ TintEFX Coloring Liquid Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 4, 2023 Received: May 9, 2023

Dear Nina Chiang:

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.

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

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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, M.ChE. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K231347

Device Name

BruxZir™ TintEFX Coloring Liquid

Indications for Use (Describe) BruxZir™ TintEFX Coloring Liquid is used for coloring pre-sintered zirconia structures.

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 shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors, including pink, blue, and yellow. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC." in blue text.

K231347

510(k) Summary

SUBMITTER I.

Prismatik Dentalcraft, Inc. 2144 Michelson Drive, Irvine, CA 92612, USA

Primary Contact Person: Nina Chiang, Regulatory Affairs Specialist Email: nina.chiang@glidewelldental.com Phone: (949) 222-2258

Secondary Contact Person: So Hyun Park, Regulatory Affairs Manager, MS Email: so.park(@glidewelldental.com Phone: (949) 863-5479

Date Prepared: May 04, 2023

II. DEVICE

Name of Device: BruxZir™ TintEFX Coloring Liquid Common Name or Usual Name: Liquid for Dental Zirconia Prosthesis Classification Name: Porcelain powder for clinical use (21 CFR 872.6660) Regulatory Class: Class II Product Code: EIH

III. PREDICATE DEVICE

BruxZir™ Opaque Coloring Liquid (K220960)

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

BruxZir™ TintEFX Coloring Liquid is used for coloring pre-sintered zirconia structures.

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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 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.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

TechnologicalCharacteristics	Subject Device(K231347)	Predicate Device(K220960)	Comparison
Device Name	BruxZir™ TintEFXColoring Liquid	BruxZir™ OpaqueColoring Liquid	N/A
Product Code	EIH	EIH	Same
Manufacturer	Prismatik Dentalcraft,Inc.	Prismatik Dentalcraft,Inc.	Same
Intended Use/Indications for Use	BruxZir™ TintEFXColoring Liquid isused for coloring pre-sintered zirconiastructures.	BruxZir™ OpaqueColoring Liquid isused for coloring pre-sintered zirconiastructures.	Same
Prescription Device	Yes	Yes	Same
DesignCharacteristics	ChemicalComposition	Aqueous solutions oftransition andlanthanide metal salts	Aqueous solutions oftransition andlanthanide metal salts	Similar;additionaltransition andlanthanidemetals and nitricacid for thesubject device
	Biocompatibility	Biocompatible	Biocompatible	Same
	Principle ofOperation	Brushing or DippingTechnique	Brushing or DippingTechnique	Same
	Type ofPackaging andVolume	Bottle; 175mL(150mL Volume)	Bottle; 175mL (150mLVolume)	Same
	Shades	Various; Brown,Green, Blue, Pink,Orange, Purple, Grey,Yellow, G00, G0, G1,G3, G4, and G5	Various; Opaq-Lite,Opaq-A, Opaq-C,Opaq, Opaq Plus	Different
	Flexural Strength	>800 MPa	>800 MPa	Same
	ChemicalSolubility	<100 µg/cm²	<100 µg/cm²	Same
	Visual ShadeEvaluation	Pass	Pass	Same
Sterility	Non-sterile	Non-sterile	Same

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The subject device, BruxZir™ TintEFX Coloring Liquid, is substantially equivalent in intended use, material, design principles and performance to the predicate device, BruxZir™ Opaque Coloring Liquid (K220960). The intended use/indications for use

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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.

for both the subject device and the predicate device are the same except for the device name. Both devices are liquids used for coloring pre-sintered zirconia restorations. The fundamental principle of operation of the subject device and the predicate device is the same. The subject device and the predicate device are similar in terms of chemical composition as both devices contain transition and lanthanide metal salts as the major constituents. The differences in terms of chemical composition does not raise any new concerns of safety and effectiveness of the subject device as the performance testing results of the subject device support that the subject device is substantially equivalent to the predicate device.

The substantial equivalence comparison table above outlines and provides the similarities between the subject device, BruxZir™ TintEFX Coloring Liquid, and the predicate device, BruxZir™ Opaque Coloring Liquid (K220960). 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 and ISO 10993.

VII. PERFORMANCE DATA

Non-clinical data submitted to demonstrate substantial equivalence included:

Mechanical testing for flexural strength and chemical solubility
Visual shade evaluation
Shelf life ●
Packaging validation ●
Biocompatibility ●

No clinical data is included in this submission.

Flexural Strength

Flexural strength testing was tested on the zirconia substrate treated with the worst case of the subject device, BruxZir™ TintEFX Coloring Liquid, per ISO 6872:2015/Amd 1:2018. The results demonstrate that the subject device applied to the zirconia substrate satisfies the minimum mechanical properties of zirconia required for Type II, Class 5 per ISO 6872:2015/Amd 1:2018. The results of the testing were used to address questions related to substantial equivalence based on differences in device design between the subject device. BruxZir™ TintEFX Coloring Liquid, and the predicate device, BruxZir™ Opaque Coloring Liquid (K220960).

Chemical Solubility

Chemical solubility was tested on the worst case. It was concluded that the solubility is below the 100 µg/cm2 limit, meeting the ISO 6872:2015/ Amd 1:2018 requirement. The result of the testing was used to address questions related to substantial equivalence based on differences in device design between the subject device, BruxZir™ TintEFX Coloring Liquid, and the predicate device, BruxZir™ Opaque Coloring Liquid (K220960).

Visual Shade Evaluation

The dental restorations were milled from zirconia milling blanks with application of the subject device, BruxZir™ TintEFX Coloring Liquid. Visual shade evaluations Prismatik Dentalcraft, Inc. 510(k) Notification BruxZir™ TintEFX Coloring Liquid

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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 a sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

were performed on the sintered and glazed restorations by qualified reviewers against reference shade guides. It was concluded that BruxZir™ TintEFX Coloring Liquid meets shade match requirements and works as intended. The results of the testing were used to address questions related to substantial equivalence based on differences in device design between the subject device, BruxZir™ TintEFX Coloring Liquid, and the predicate device, BruxZir™ Opaque Coloring Liquid (K220960).

Shelf Life

The accelerated aging test was performed per ASTM F1980-21 to establish the shelf life of the subject device, BruxZir™ TintEFX Coloring Liguid. It was concluded that the shelf life of BruxZir™ TintEFX Coloring Liquid is 0.5 years. The results of the testing were used to address questions related to substantial equivalence based on differences in shelf life between the subject device, BruxZir"M TintEFX Coloring Liquid, and the predicate device, BruxZir™ Opaque Coloring Liquid (K220960).

Packaging Validation

Packaging configurations were evaluated to ensure that it is suitable to withstand the distribution environment such that the device packaged in a bottle can be sent to a customer undamaged. The subject device, BruxZir™ TintEFX Coloring Liquid, uses the same packaging materials and packaging configurations as the predicate device, BruxZir™ Opaque Coloring Liquid (K220960). The results of the previous packaging validation were used to address questions related to substantial equivalence based on differences in packaging configuration between the subject device, BruxZir"M TintEFX Coloring Liquid, and the predicate device, BruxZir™ Opaque Coloring Liquid (K220960).

Biocompatibility

The subject device, BruxZir™ TintEFX Coloring Liquid, was tested in accordance with ISO 10993-1. Per the biological evaluation, BruxZir™ TintEFX Coloring Liquid was tested for Cytotoxicity (ISO 10993-5:2009), Skin Sensitization (ISO 10993-10:2021), and Oral Mucosal Irritation (ISO 10993-10:2021) to meet the biocompatibility requirements. Based on the biocompatibility testing results, it was determined that there is no biocompatibility concern for the subject device. The results of the testing were used to address questions related to substantial equivalence based on differences in chemical composition between the subject device, BruxZir"M TintEFX Coloring Liquid, and the predicate device. BruxZirTM Opaque Coloring Liquid (K220960).

VIII. CONCLUSION

Based on the technological characteristics and non-clinical test data included in this submission, BruxZirTM TintEFX Coloring Liquid has been shown to be substantially equivalent to the predicate device. BruxZir™ Opaque Coloring Liquid (K220960).

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.