BruxZir® NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

Device Description

BruxZir® NOW is a pre-shaded, fully sintered zirconia CAD/CAM block used for fabricating single-unit or multiple-unit dental restorations. BruxZir® NOW is used for fabricating single-unit dental restorations, while BruxZir® NOW Bridge Block is used for fabricating multiple-unit dental restorations. BruxZir® NOW is available in the following shades: Bleach White, Bleach 1, Bleach 3, and 16 VITA Classical shades (A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4). BruxZir® NOW Bridge Block is available in the following 6 VITA Classical shades: A1, A2, A3, B1, C2, D2. The method of fabricating the restoration is with CAD/CAM milling systems.

AI/ML Overview

The provided text describes the regulatory clearance of a dental material, BruxZir® NOW, and its comparison to a predicate device, Perfit FS Dental Zirconia Fully Sintered Block. The information primarily focuses on demonstrating substantial equivalence rather than a study proving the device meets acceptance criteria in the context of an AI/ML device.

However, I can extract the relevant performance data and acceptance criteria as described for the dental material itself. The document does not describe an AI/ML device, an MRMC study, or a standalone algorithm performance study. It's about a physical dental material.

Here's the information based on the provided text, interpreted for the dental material:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (ISO/ASTM Standards)	BruxZir® NOW Performance
Flexural Strength:	>800 MPa
Type II Class 5 per ISO 6872:2015/Amd 1:2018 (>800 MPa)
Solubility:	<100 µg/cm²
<2000 µg/cm² (ISO 6872:2015/Amd 1:2018 requirement)
Radioactivity (Uranium-238):	Below 1.0 Bq/g
No more than 1.0 Bq/g (ISO 6872:2015/Amd 1:2018)
Biocompatibility:	No biocompatibility concern determined
In accordance with ISO 10993-1:2018 and ISO 14971:2019
Shade Evaluation:	Meets shade match requirements and works as intended
(Evaluated against VITA Classical and reference Bleach shade guides)
Packaging Validation:	Suitable for use (withstands distribution environment)
Per ASTM D4169-16 (resistance against manual handling, vehicle stacking, loose load vibration, vehicle vibration, and concentrated impact)

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

Flexural Strength: Tested on "worst-case groups" for two types of BruxZir® NOW and BruxZir® NOW Bridge Block. Specific sample size not provided.
Solubility: "The worst case was tested." Specific sample size not provided.
Shade Evaluation: "All shades offered for BruxZir® NOW were evaluated." Specific sample size (number of restorations/blocks) not provided.
Biocompatibility: Based on cytotoxicity testing results from the subject device, BruxZir® NOW. Specific sample size not provided.
Radioactivity: "BruxZir® NOW was tested." Specific sample size not provided.
Packaging Validation: "BruxZir® NOW and BruxZir® NOW Bridge Block were tested." Specific sample size not provided.

The data provenance is from non-clinical testing conducted by Prismatik Dentalcraft, Inc. (USA). The nature of the tests (e.g., lab bench testing, material property measurements) makes the retrospective/prospective distinction less applicable in the same way as for clinical data.

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

Shade Evaluation: "qualified evaluators." Number and specific qualifications of these evaluators are not provided.
For other tests (Flexural Strength, Solubility, Radioactivity, Biocompatibility, Packaging Validation), the "ground truth" is established by adherence to recognized international standards (ISO, ASTM) and physical/chemical measurements, not typically by human expert consensus on individual cases.

4. Adjudication Method for the Test Set

Not applicable as the testing involves physical/chemical properties measured against defined standards, not human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This document describes a physical dental material, not an AI/ML diagnostic or assistive device.

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

No, a standalone algorithm performance study was not done. This document describes a physical dental material, not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for the material's properties is derived from measurements against established international standards (ISO 6872:2015/Amd 1:2018, ISO 10993-1:2018, ISO 14971:2019, ASTM D4169-16). For shade evaluation, it was comparison against "VITA Classical shade guide and reference Bleach shade guide."

8. The Sample Size for the Training Set

Not applicable. This document describes a physical dental material, not an AI/ML device that requires a training set.

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

Not applicable. This document describes a physical dental material, not an AI/ML 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, there 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.

August 2, 2022

Prismatik Dentalcraft, Inc. So Hyun Park Regulatory Affairs Manager 2144 Michelson Drive Irvine, California 96212

Re: K220816

Trade/Device Name: BruxZir NOW Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: June 2, 2022 Received: June 3, 2022

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

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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 (OS) 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) K220816

Device Name BruxZir® NOW

Indications for Use (Describe)

BruxZir® NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

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

510(k) Summary

I. SUMBITTER

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/QA Email: Herbert.crane(@glidewelldental.com Phone: (949) 222-3531

Date Prepared: July 19, 2022

II. DEVICE

Name of Device: BruxZir® NOW Common Name or Usual Name: Zirconia Milling Block or Dental CAD/CAM Block Classification Name: Porcelain powder for clinical use (21 CFR 872.6660) Regulatory Class: Class II Product Code: EIH

III. PREDICATE DEVICE

Primary Predicate Device: Perfit FS Dental Zirconia Fully Sintered Block (K203590) Reference Device: BruxZir® Shaded (K130924)

IV. DEVICE DESCRIPTION

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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.

INDICATIONS FOR USE V.

BruxZir® NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

	TechnologicalCharacteristics	Subject Device(K220816)	Predicate Device(K203590)	Comparison
TechnologicalCharacteristics	Device Name	BruxZir® NOW	Perfit FS DentalZirconia FullySintered Block	N/A
	Manufacturer	Prismatik Dentalcraft,Inc.	Vatech Acucera, Inc.	N/A
	Product Code	EIH	EIH	Same
	Prescription Device	Yes	Yes	Same
	Intended Use	BruxZir® NOW isintended to be used infabrication of dentalrestorations such ascrowns and bridges forthe purpose ofrestoring chewingfunction.	Perfit FS DentalZirconia Fully SinteredBlock is intended to beused in fabrication ofdental restorations suchas crowns and bridgesfor the purpose ofrestoring chewingfunction.	Same
DesignCharacteristics	Indications for Use	BruxZir® NOW isused for dentalrestorations usingdifferent CAD/CAM ormanual millingmachines. All blocksare processed throughdental laboratories orby dental professionals.	Perfit FS DentalZirconia Fully SinteredBlock is used for dentalrestorations usingdifferent CAD/CAM ormanual millingmachines. All blocksare processed throughdental laboratories orby dental professionals.	Same except for thedevice trade name
	MaterialComposition	The device iscomposed of Yttria-stabilized zirconia(YSZ) and pigments toachieve the desiredshades.	The device iscomposed of Yttria-stabilized zirconia(YSZ) and pigments toachieve the desiredshades.	Similar, both the subjectdevice and the predicatedevice are composed ofYttria- stabilized zirconiaas the primarycomponent and the
TechnologicalCharacteristics	Subject Device(K220816)	Predicate Device(K203590)	Comparison
Design	Fully sintered zirconiablock available inblock form in 2 sizesfor single and multiple-unit restorations	Fully sintered zirconiablock available in blockform in various sizes	desired shades areachieved by usingdifferent pigments.Different; The subjectdevice and the predicatedevice are offered indifferent shapes andsizes.
Shades	BruxZir® NOW isavailable in thefollowing shades:Bleach White, Bleach1, Bleach 3, and 16VITA Classical shades(A1, A2, A3, A3.5, A4,B1, B2, B3, B4, C1,C2, C3, C4, D2, D3,D4). BruxZir® NOWBridge Block isavailable in thefollowing 6 VITAClassical shades: A1,A2, A3, B1, C2, D2.	There are whitezirconia products(White) and coloredzirconia products, andcolored zirconia is alsodivided into Monolayer(A1, A2, A3.5, A4, B1,B2, B3, B4, C1, C2,C3, C4, D2, D3, D4)color products, Shademulti-layer (MLA1/A2/A3, A1M,A2M, A3M, A3.5M,A4M) colorproducts.	Different; The subjectdevice and the predicatedevice are provided indifferent shades.
FlexuralStrength	>800 MPaType II Class 5 perISO 6872:2015/Amd1:2018	≥ 500 MPaType II Class 4 per ISO6872:2015/Amd 1:2018	Different; The flexuralstrength of the subjectdevice is >800 MPa,which is higher than theflexural strength of thepredicate device. ISOclassification is alsodifferent due to thedifference in flexuralstrength.
Biocompatibility	Biocompatible per ISO10993-1	Biocompatible per ISO10993-1	Same
Solubility	<100 µg/cm²	<2000 µg/cm²	Different; The subjectdevice meets the ISOsolubility requirement forClass 5.
Radioactivity	The activity	The activity	Same
Technological	Subject Device	Predicate Device	Comparison
Characteristics	(K220816)	(K203590)
	Uranium-238 is nomore than 1.0 Bq/g.	Uranium-238 is nomore than 1.0 Bq/g.

Prismatik Dentalcraft, Inc. 510(k) Notification BruxZir® NOW March 2022

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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 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.

Prismatik Dentalcraft, Inc. 510(k) Notification
BruxZir® NOW
March 2022

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Image /page/6/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangle on the left side, with the company name written in blue text on the right side. The triangle is divided into several sections, each with a different color, creating a prism-like effect. The text is simple and easy to read.

K220816

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The subject device, BruxZir® NOW, is substantially equivalent to the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590) in intended use, indications for use, material, design principles and technological characteristics.

The subject device, BruxZir® NOW, has the same intended use as the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590), as the material used in fabrication of dental restorations such as crowns and bridges for the purpose of restoring chewing function. The subject device, BruxZir® NOW, has the same indications for use statement (IFUS) as the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590), except for the device trade name. Both the subject device and the predicate device are dental restorative materials indicated for fabrication of dental restorations using CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

The subject device, BruxZir® NOW, is substantially equivalent to the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590), in technological characteristics. The same mechanical property testing in terms of flexural strength that was conducted on the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590), was also conducted on the subject device, BruxZir® NOW, according to ISO 6872:2015/Amd 1:2018. The flexural strength of the subject device, BruxZir® NOW, passed the threshold of performance criteria in ISO 6872 for Type II Class 5. The flexural strength of the subject device, BruxZir® NOW, is higher than that of the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590), which passed the threshold of performance criteria in ISO 6872 for Type II, Class 4.

The subject device, BruxZir® NOW, and the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590), are similar in material composition. Both devices utilize Yttria-stabilized zirconia as the base material and pigments. Despite the differences in the pigments used to achieve the desired shades, the slight differences in chemical formulation do not affect the safety and effectiveness of the device as verified by the biocompatibility and performance testing.

The subject device, BruxZir® NOW, and the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590), are substantially equivalent in terms of design. Both are offered in a fully sintered block form in different shapes and shades and are used to make

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Image /page/7/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, red, yellow, green, blue, and purple. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a sans-serif font.

final dental restorations based on the anatomical rendering of the patient's teeth using CAD/CAM equipment.

VII. PERFORMANCE DATA

Non-clinical data submitted to demonstrate substantial equivalence include:

Flexural Strength according to ISO 6872:2015/Amd 1:2018 ●
Solubility according to ISO 6872:2015/Amd 1:2018 ●
Shade evaluation
Biocompatibility according to ISO 10993-1:2018 ●
Radioactivity according to ISO 6872:2015/Amd 1:2018
Packaging Validation according to ASTM D4169-16 ●

No clinical data is included in this submission.

Flexural Strength

Flexural strength was tested on the worst-case groups for two types of BruxZir® NOW and BruxZir® NOW Bridge Block. The average flexural strength of each worst-case yielded the results above the minimum threshold of 800 MPa, which is the value to be achieved for Type II Class 5 ceramic product according to ISO 6872:2015/Amd 1:2018. The results of the testing were used to address questions related to substantial equivalence based on differences in technical specifications between the subject device, BruxZir® NOW, and predicate device. Perfit FS Dental Zirconia Fully Sintered Block (K203590).

Solubilitv

The worst case was tested for solubility and the measured value was <100 ug/cm² 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 technical specifications between the subject device, BruxZir® NOW, and predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590).

Shade Evaluation

All shades offered for BruxZir® NOW were evaluated by the qualified evaluators using the sample dental restorations milled from the final sintered products against the corresponding VITA Classical shade guide and reference Bleach shade guide. Evaluations concluded that BruxZir® NOW 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 technical specifications between the subject device, BruxZir® NOW, and predicate device. Perfit FS Dental Zirconia Fully Sintered Block (K203590).

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Image /page/8/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left side that is filled with a gradient of colors, including pink, red, yellow, green, and blue. To the right of the triangle is the text "PRISMATIK" in a larger, bold, blue font, with the text "DENTALCRAFT, INC." underneath it in a smaller, bold, blue font.

Biocompatibility

Biological evaluation within a risk management process was performed in accordance with ISO 10993-1:2018 and ISO 14971:2019. Based on the cytotoxicity testing results from the subject device, BruxZir® NOW, it was determined that there is no biocompatibility concern regarding yttria concentration, colorants, or other elements. 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® NOW, and the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590).

Radioactivity

BruxZir® NOW was tested to meet the radioactivity requirement of ISO 6872:2015/Amd 1:2018. BruxZir® NOW meets the radioactivity requirement since the sample measured below the Uranium-238 activity threshold of 1.0 Bq.g1 set by ISO 6872:2015/Amd 1:2018. The result of the testing was used to address questions related to substantial equivalence based on differences in technical specifications between the subject device, BruxZir® NOW, and predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590).

Packaging Validation

The packaging validation was conducted to ensure that the packaging configurations for tBruxZir® NOW are suitable to withstand the distribution environment. Per ASTM D4169-16, BruxZir® NOW and BruxZir® NOW Bridge Block were tested to check resistance against manual handling, vehicle stacking, loose load vibration, vehicle vibration, and concentrated impact. After the test, the shipping containers were visually inspected for any damages. It was determined that the respective packaging for BruxZir® NOW blocks is suitable for use. The results of the testing were used to address questions related to substantial equivalence based on differences in product packaging between the subject device, BruxZir® NOW, and predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590).

VIII. CONCLUSION

Based on the technological characteristics and non-clinical test data included in this submission, the subject device, BruxZir® NOW, has been shown to be substantially equivalent to the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590).

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.