BruxZir Steel by Prismatik Dentalcraft, Inc.

BruxZir Steel™ can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading and to produce a strong prosthesis with a porcelain-like finish. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.

Device Description

BruxZir Steel™ is a Coloring Liquid used to produce a natural whitening effect while increasing the flexural strength and fracture toughness of 4.6 - 4.9 mol% yttriastabilized zirconia (YSZ). The product increases the shade esthetics of the restoration while maintaining the translucency. Application of the zirconia substrate prior to sintering provides enhanced shade characteristics and improved flexural strength and fracture toughness.

AI/ML Overview

This document pertains to the 510(k) premarket notification for BruxZir Steel™, a dental coloring liquid. The submission focuses on demonstrating substantial equivalence to a predicate device, DMAX Coloring Liquid (K173769), and referencing ZirBlank®-FS (K070045) for certain features.

Based on the provided text, the device is a Class II dental device (Regulation Number: 21 CFR 872.6660, Product Code: EIH). The evaluation presented is primarily a non-clinical study to demonstrate performance characteristics and biocompatibility. As such, the concept of "acceptance criteria" and "device performance" relating to clinical outcomes, AI assistance, or human reader studies is not applicable here. Similarly, ground truth establishment would refer to laboratory testing standards rather than expert consensus on medical images.

Here's an analysis of the provided information within the context of this specific device's evaluation:

1. Table of Acceptance Criteria and Reported Device Performance

For this non-clinical submission, the "acceptance criteria" are based on meeting established standards for dental materials and demonstrating properties comparable to or exceeding those of predicate/reference devices.

Acceptance Criteria (Standard / Comparator)	Reported Device Performance (BruxZir Steel™)
Biocompatibility:	Biocompatible (No evidence of cell lysis/toxicity, no reaction on tested subject, non-irritant)
Cytotoxicity (ISO 10993-5:2009)	Passed (No evidence of causing cell lysis or toxicity)
Sensitization (ISO 10993-10:2010)	Passed (No reaction on the tested subject)
Irritation (ISO 10993-10:2010)	Passed (Considered a non-irritant)
Mechanical Properties (referencing ISO 6872:2015):
Flexural Strength of Tantalum Treated Zirconia: (Reference Device: 600 MPa)	1 GPa (This exceeds the reference device's flexural strength, indicating improved performance.)
Fracture Toughness of Tantalum Treated Zirconia: (Reference Device: ≥5.0 MPa · m1/2)	≥5.0 MPa · m1/2 (Meets the reference device's fracture toughness.)
Solubility of Tantalum Treated Zirconia: (Predicate/Reference: ≤ 100 µg/cm²)	≤ 100 µg/cm² (Meets the standard/predicate/reference device's solubility limit, confirming low solubility.)
Color Space Testing (referencing ISO 11664-4:2019):	L* value obtained (Specific value not provided, but testing was conducted to assess shade esthetics and translucency.)
Substantial Equivalence:	Device demonstrated substantial equivalence to the predicate in intended use, material, design, and performance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each non-clinical test (e.g., number of samples for flexural strength, number of animals for biocompatibility). However, it indicates that testing was performed according to the specified ISO standards (ISO 10993-5:2009, ISO 10993-10:2010, ISO 6872:2015, ISO 11664-4:2019). These standards typically define minimum sample sizes for reliable results.

Data Provenance: The studies are non-clinical, laboratory-based tests conducted by the manufacturer, Prismatik Dentalcraft, Inc. The country of origin of the data is not explicitly stated but is implied to be in the USA, where the company is located (Irvine, California). The studies are prospective in nature, as they were conducted specifically to support this FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable in the traditional sense of medical imaging or clinical diagnostic studies. For non-clinical performance and biocompatibility testing, "ground truth" is established by adherence to validated international standards and protocols. The "experts" would be the chemists, material scientists, and laboratory technicians performing the tests, whose qualifications are implicit in their ability to conduct such highly technical and standardized evaluations. There is no mention of a panel of human experts reviewing test results for "ground truth" adjudication.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving reader interpretations. For non-clinical laboratory tests, the results are quantitative measurements or qualitative assessments (e.g., pass/fail for biocompatibility) based on predefined criteria within the test standards, not on expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that are interpreted by multiple human readers (e.g., radiologists interpreting images) to assess the impact of a device (like AI assistance) on human performance. BruxZir Steel™ is a dental material, not a diagnostic imaging device, and its evaluation did not involve human readers interpreting cases.

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

Not Applicable. This concept applies to AI algorithms. BruxZir Steel™ is a physical dental material; it does not involve any AI algorithm or software.

7. The Type of Ground Truth Used

For this submission, the "ground truth" for the device's performance characteristics was based on:

Established International Standards: ISO 10993 (Biocompatibility), ISO 6872 (Mechanical Properties), and ISO 11664-4 (Colorimetry). These standards dictate the methodologies and criteria for evaluating the material properties.
Reference Devices: Performance criteria were also benchmarked against the properties of the ZirBlank®-FS (K070045) reference device for flexural strength, fracture toughness, and solubility.

8. The Sample Size for the Training Set

Not Applicable. This term refers to the data used to train machine learning models. BruxZir Steel™ is a physical medical device, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As explained above, there is no AI/ML model or "training set" for this device.

Summary

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June 10, 2020

Prismatik Dentalcraft, Inc. So Hyun Park Sr. Regulatory Affairs Specialist 2212 Dupont Drive. Suite P Irvine, California 92612

Re: K200131

Trade/Device Name: BruxZir Steel™ Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 15, 2020 Received: May 18, 2020

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 (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 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,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K200131

Device Name BruxZir Steel™

Indications for Use (Describe)

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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510(k) Summary

SUBMITTER INFORMATION A.

Company Name:	Prismatik Dentalcraft, Inc.
Company Address:	2212 Dupont Drive, Suite PIrvine, CA 92612
Company Phone:	+1 949-863-5479
Company Fax:	+1 949-553-0924
EstablishmentRegistration Number:	3011649314
Primary Contact Person:	So Hyun ParkSr. Regulatory Affairs SpecialistSo.park@glidewelldental.com
Secondary Contact Person:	Herbert SchoenhoeferRA/QA DirectorHerbert.Schoenhoefer@glidewelldental.com+1 949-440-2632
Date Summary Prepared:	June 9, 2020
DEVICE IDENTIFICATION

Trade/Proprietary Name:	BruxZir Steel™
Common Name:	Dental restorative material
Classification Name:	Porcelain powder for clinical use
Regulation Number:	21 CFR 872.6660
Product Code:	EIH
Device Class:	Class II
Classification Panel	Dental Products Panel
Reviewing Branch:	Dental Devices Branch

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C. IDENTIFICATION OF PREDICATE DEVICE

Primary Predicate: DMAX Coloring Liquid (K173769)

Reference Device: ZirBlank®-FS (K070045)

D. DEVICE DESCRIPTION

E. INDICATIONS FOR USE

F. DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The subject device, BruxZir Steel™, is substantially equivalent to the primary predicate device, DMAX Coloring Liquid, (K173769) in intended use, material, design and performance.

The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate. Both the subject device and the primary predicate device can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading and intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients. Slight difference in the subject device and primary predicate device Indications for Use does not affect the intended use and is supported by the reference device, ZirBlank®-FS (K070045). The subject device and the reference device include tantalum. The performance testing data also supports a new indication for use by showing that the subject device increases the flexural strength and fracture toughness of zirconia. Both IFUS express equivalent intended use to facilitate fabrication of zirconium dioxide restorations for individual dental patients, and indication for a strong prosthesis with a porcelain-like finish is expressed equivalently using different specific wording.

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K200131

The differences between the predicate device and the subject device in terms of chemical composition are the presence of tantalum(V) oxide, less amount of silicon dioxide, and absence of sodium in the subject device. After sintering, the remaining tantalum pentoxide, which is incorporated into the zirconia substrate, is proven biocompatible. Silicon dioxide in the predicate device is a whitening agent, which makes the zirconia restoration whiter. The absence of sodium in the subject device does not affect the intended use.

Although the base solutions for BruxZir Steel™ and DMAX Coloring Liquid are not identical (i.e. alcohol-based solution and water-based solution respectively), the difference does not affect the intended use, performance characteristics, or principle of operation.

The subject device and the reference device employ tantalum prior to sintering the zirconia substrate. Substantial equivalence of the subject device components to the reference device in terms of biocompatibility is supported by the fact that tantalum has been acknowledged as being biocompatible for use in dental applications. Nonetheless, biocompatibility testing was performed on the subject device and the device was proven biocompatible.

The comparison table below (Table 7-1) outlines and provides the similarities and differences among the subject device, primary predicate device and reference device.

In summary, the subject device is substantially equivalent to the predicate device.

PERFORMANCE DATA G.

Non-clinical data submitted to demonstrate substantial equivalence included:

Biocompatibility according to ISO 10993-5:2009 and ISO 10993-10:2010 ●
- The Cytotoxicity Report shows that there was no evidence of causing cell । lysis or toxicity.
- The Sensitization Report shows that there was no reaction on the tested subject.
- The Irritation Report shows that the test article was considered a nonirritant. -
Mechanical testing for flexural strength, fracture toughness, solubility . according to ISO 6872:2015
. L* value obtained from Lab* color space testing after applying BruxZir Steel™ onto zirconia for dental restoration according to ISO 11664-4:2019.

Biological evaluation within a risk management process was performed in accordance with ISO 10993-1:2018 and EN ISO 14971:2012. No clinical data were included in this submission.

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CONCLUSION H.

The documentation submitted in this premarket notification demonstrates that the BruxZir Steel™ is substantially equivalent to the predicate device.

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Table 7-1 – Comparison between predicate device and subject device

Feature	Subject Device	Primary Predicate	Reference Device
Device Name	BruxZir Steel™	DMAX Coloring Liquid	ZirBlank®-FS
510(k)	K200131	K173769	K070045
Regulation	21 CFR 872.6660	21 CFR 872.6660	21 CFR 872.6660
Product Code	EIH	EIH	EIH
Classification	II	II	II
Indications for Use	BruxZir Steel™ can be used asan accessory to zirconiumdioxide dental restorativematerial to provide individualtooth (or teeth) shading and toproduce a strong prosthesis witha porcelain-like finish. It isintended to be used solely bycertified dental technicians forfabrication of zirconium dioxiderestorations for individual dentalpatients.	DMAX coloring liquid can beused as an accessory to zirconiumdioxide dental restorative materialto provide individual tooth (orteeth) shading. It is intended to beused solely by certified dentaltechnicians for fabrication ofzirconium dioxide restorations forindividual dental patients.	Intended for use inpreparation of crowns,facings, inlays and onlays - toproduce a hard prosthesiswith a porcelain-like finish.Frequently used withporcelain overlay fortranslucence and related effects.For fabricating copings andframeworks for inlays, onlays,veneers, crowns, anterior andposterior bridge restorations.Intended to restore carious lesionsor structural defects in teeth. It isintended for use in cavities ClassesI, II, and V (inlays and onlays) andas a restorative material intendedfor veneers, crowns and bridges.
Feature	Subject Device	Primary Predicate	Reference Device
Contraindication	Do not use on 3Y zirconia.	None	None
PrescriptionDevice	Yes	Yes	Yes
Environment ofUse	Dental laboratories	Dental laboratories	Dental laboratories
Design	Alcohol-based TantalumEthoxide solution withburn-out at 100% duringsintering, which isincorporated into a zirconiasubstrate as sub-micron sizedTantalum Pentoxide	Water-based with inorganicpigments applied to zirconiumdioxide dental restorative materialbefore sintering	Tantalum Pentoxide added to ayttrium oxide-stabilized zirconia(Y-TZP)
Principle ofOperation	Brush zirconia ceramic withcoloring liquid before sintering	Brush or immerse zirconiaceramic with coloring liquidbefore sintering	Not Applicable
Shade	1 color	45 colors	Not Applicable
Storage Conditions	Store at 22-25°C	Store at 2-28°C	Store at room temperature
Flexural Strengthof TantalumTreated Zirconia	1 GPa	Not Applicable	600 MPa
FractureToughness ofTantalum TreatedZirconia	$≥5.0 MPa · m1/2$	Not Applicable	$≥5.0 MPa · m1/2$
Feature	Subject Device	Primary Predicate	Reference Device
Solubility ofTantalum TreatedZirconia	$ \leq $ 100 µg/cm²	$ \leq $ 100 µg/cm²	$ \leq $ 100 µg/cm²
Biocompatibility	Biocompatible	Biocompatible	Biocompatible
Sterility	Non-Sterile	Non-Sterile	Non-Sterile

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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.