BruxZir™ Opaque 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™ Opaque Coloring Liquid is available in different colors, Opaq-Lite, Opaq-A, Opaq-C, Opaq, Opaq Plus. 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 premarket notification (510(k)) for the BruxZir™ Opaque Coloring Liquid, a dental device. The information provided outlines the device's technical characteristics and the performance data submitted to demonstrate substantial equivalence to a predicate device.

Key takeaway: This submission focuses on the chemical and mechanical properties of the coloring liquid and its effect on zirconia, not on the performance of an AI-powered medical device. Therefore, many of the requested criteria regarding AI device studies (like sample size for data provenance, expert ground truth establishment, MRMC studies, etc.) are not applicable to this document.

However, I can extract the relevant acceptance criteria and performance data for this specific type of dental product:

Acceptance Criteria and Reported Device Performance

None of the provided sections deal with general medical device acceptance criteria. However, specific performance tests and their conclusions are mentioned in the "PERFORMANCE DATA" section (VII). These can be interpreted as the "acceptance criteria" met by the device.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Test Performed)	Performance Measurement / Standard	Reported Device Performance
Flexural Strength	Does not significantly affect the mechanical property of zirconia substrate. (Per ISO 6872:2015/Amd 1:2018)	The results demonstrated that the subject device does not significantly affect the mechanical property of zirconia substrate. The testing addressed substantial equivalence based on differences in device design.
Solubility	Solubility below 100 µg/cm² limit. (Per ISO 6872:2015/Amd 1:2018)	The solubility was concluded to be below 100 µg/cm² limit, meeting the ISO 6872:2015/Amd 1:2018 requirement (tested on the worst case with all 5 shades). The testing addressed substantial equivalence based on differences in device design.
Visual Shade Evaluation	Meets shade match requirements and works as intended (visual assessment against reference shade guides).	It was concluded that BruxZir™ Opaque Coloring Liquid meets shade match requirements and works as intended. The testing addressed substantial equivalence based on differences in device design.
Shelf Life	Establishes a shelf life. (Per ASTM F1980-16 for accelerated aging)	It was concluded that the shelf life of BruxZir™ Opaque Coloring Liquid is 2 years. The results addressed substantial equivalence based on differences in shelf life.
Packaging Validation	No damage to packaged contents or leaks of coloring liquids after distribution simulation. (Per ASTM D4169-16)	Visual examination of the parts did not reveal any damage of the packaged contents and any leaks of the coloring liquids, and revealed that the seal of the bottles was intact. The testing addressed substantial equivalence based on differences in packaging configuration.
Biocompatibility	Meets biocompatibility requirements (Cytotoxicity, Sensitization, Oral Mucosal Irritation) (Per ISO 10993-1, 10993-5:2009, 10993-10:2010).	Based on the biocompatibility testing results (Cytotoxicity, Sensitization, Oral Mucosal Irritation), it was determined that there is no biocompatibility concern for the subject device. The testing addressed substantial equivalence based on differences in chemical composition.

Further Requested Information (and why it's not applicable in this context):

Given that this is a 510(k) submission for a dental coloring liquid, not an AI-powered diagnostic or therapeutic device, most of the remaining questions are not directly addressed in the provided document, as they pertain to clinical studies, AI algorithms, and human-in-the-loop performance evaluation.

Sample size used for the test set and the data provenance: Not applicable. Tests involve material properties and physical assessments, not clinical data sets in the typical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For "Visual Shade Evaluation," "qualified reviewers" are mentioned, but the number and specific qualifications are not detailed. For material property tests, ground truth is established by standardized testing methods (e.g., ISO, ASTM).
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for material and physical property testing. Visual shade evaluation would likely have involved a consensus or multiple assessments, but details are not provided.
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 device is a dental coloring liquid, not an AI system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth was established by adherence to recognized international standards (ISO, ASTM) for physical and chemical properties, and subjective "shade match requirements" for visual evaluation.
The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established: Not applicable.

In conclusion, the document provides evidence of the device's compliance with established material and performance standards relevant to dental coloring liquids, ensuring its substantial equivalence to a predicate device. It does not involve AI or the associated clinical study methodologies.

Summary

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June 29, 2022

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

Re: K220960

Trade/Device Name: BruxZir Opaque Coloring Liquid Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: March 31, 2022 Received: April 1, 2022

Dear So 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.

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

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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,

For 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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Indications for Use

510(k) Number (if known)

K220960

Device Name BruxZir™ Opaque Coloring Liquid

Indications for Use (Describe)

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

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

X 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.

K220960 510(k) Summary

I. SUBMITTER

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

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

Secondary Contact Person: Herbert Crane, VP RA/OA Email: Herbert.Crane@glidewelldental.com Phone: (949) 222-3531

Date Prepared: June 24, 2022

DEVICE II.

Name of Device: BruxZir™ Opaque 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. PRIMARY PREDICATE DEVICE

Zirkonzahn COLOUR LIQUID (K190518)

DEVICE DESCRIPTION IV.

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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.

V. INDICATIONS FOR USE

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

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

TechnologicalCharacteristics	Subject Device(TBD)	Predicate Device(K190518)	Comparison
DesignCharacteristics	Device Name	BruxZirTM OpaqueColoring Liquid	Zirkonzahn COLOURLIQUID	N/A
	Product Code	EIH	EIH	Same
	Manufacturer	Prismatik Dentalcraft, Inc.	ZIRKONZAHN SRL	N/A
	Intended Use/Indications for Use	BruxZirTM OpaqueColoring Liquid is usedfor coloring pre-sinteredzirconia structures.	Zirkonzahn COLOURLIQUID is used forcoloring pre-sinteredzirconia structures.	Same except for thedevice name
	Prescription Device	Yes	Yes	Same
	ChemicalComposition	Aqueous solutions oftransition and lanthanidemetal salts	Aqueous solutions oftransition and lanthanidemetal salts	Similar
	Biocompatibility	Biocompatible	Biocompatible	Same
	Principles ofOperation	Brushing or DippingTechnique	Brushing or DippingTechnique	Same
	Type of Packagingand Volume	Bottle; 175mL	Bottle; 20mL, 50mL,100mL	Similar
	Shade	Various; Opaq-Lite,Opaq-A, Opaq-C, Opaq,Opaq Plus	Various; A1-D4	Similar
	Sterility	Non-sterile	Non-sterile	Same

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The subject device, BruxZir™ Opaque Coloring Liquid, is substantially equivalent in intended use, material, design principles and performance to the predicate device, Zirkonzahn COLOUR LIQUID (K190518). The intended use/indications for use 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 same. The subject device and the predicate device are similar in terms of chemical composition as both devices contain transition and lanthanide metals as the major constituents.

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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.

The substantial equivalence comparison table above outlines and provides the similarities between the subject device, BruxZir™ Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518). 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. And differences between the subject device and the predicate device do not raise any new concerns of safety and effectiveness.

VII. PERFORMANCE DATA

Non-clinical data submitted to demonstrate substantial equivalence include:

Mechanical testing for flexural strength and solubility ●
Vishal shade evaluation
Shelf life
Packaging validation .
Biocompatibility

No clinical data is included in this submission.

Flexural Strength

Flexural strength testing was performed on the zirconia substrate treated with the subject device, BruxZir™ Opaque Coloring Liquid, per ISO 6872:2015/Amd 1:2018. The results of the testing demonstrated that the subject device does not significantly affect the mechanical property of zirconia substrate. 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™ Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).

Solubility

Chemical solubility was tested on the worst case, which is the zirconia substrate with all 5 shades of the subject device, BruxZir"™ Opaque Coloring Liquid applied. It was concluded that the solubility is below 100 ug/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, BruxZirTM Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).

Visual Shade Evaluation

The dental restorations were milled from the zirconia milling blanks with application of the subject device, BruxZir™ Opaque Coloring Liquid. Visual shade evaluations were performed on the sintered and glazed restorations by qualified reviewers against the reference shade guides. It was concluded that BruxZir"M Opaque 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

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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.

device design between the subject device, BruxZir™ Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).

Shelf Life

The accelerated aging test was performed per ASTM F1980-16 in order to establish the shelf life of the subject device, BruxZir™ Opaque Coloring Liquid. It was concluded that the shelf life of BruxZir™ Opaque Coloring Liquid is 2 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™ Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).

Packaging Validation

Packaging validation was performed on the subject device, BruxZir1M Opaque Coloring Liquid. Per ASTM D4169-16, the shipping unit was tested for manual handling drops, vehicle stacking, loose load vibration, low pressure hazard, vehicle vibration and concentrated impact. Following distribution simulation testing, the packaging contents were visually inspected for signs of damages, or leaks. Visual examination of the parts did not reveal any damage of the packaged contents and any leaks of the coloring liquids and revealed that the seal of the bottles was intact. The results of the testing were used to address questions related to substantial equivalence based on differences in packaging configuration between the subject device, BruxZir™ Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).

Biocompatibility

The subject device, BruxZir™ Opaque Coloring Liquid, was tested in accordance with ISO 10993-1. Per the biological evaluation, BruxZir™ Opaque Coloring Liquid was tested for Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010) and Oral Mucosal Irritation (ISO 10993-10:2010) 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 Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).

VIII. CONCLUSION

Based on the technological characteristics and non-clinical test data included in this submission, the subject device, BruxZir"M Opaque Coloring Liquid, has been shown to be substantially equivalent to the primary predicate device, Zirkonzahn COLOUR LIQUID (K190518).

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.