K Number

Device Name

BruxZir Esthetic

Manufacturer

Prismatik Dentalcraft, Inc.

Date Cleared

2021-11-17

(27 days)

Product Code

EIH

Regulation Number

872.6660

Intended Use

The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

Device Description

BruxZir® Esthetic blanks are zirconia milling blanks used for the production of esthetic zirconia dental restorations. The high esthetics and high strength of BruxZir® Esthetic 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® Esthetic blanks are available in white and pre-shaded varieties that can be easily adjusted to match the final shade.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K130924

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the material properties and manufacturing process of zirconia blanks for dental restorations, utilizing standard CAD/CAM technology. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No.
The device is a material (zirconia milling blanks) used to construct dental restorations, not a device directly used for therapy or treatment.

Diagnostic

This device is a material (zirconia milling blanks) used to construct dental restorations, not to diagnose a condition. Its use is in fabrication, not medical assessment.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical zirconia milling blank used in a CAD/CAM system to produce dental restorations, which are then sintered. This involves physical materials and manufacturing processes, not just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for dental technicians to construct custom-made dental restorations. This is a manufacturing process for a medical device that will be placed in the body, not a diagnostic test performed on a sample from the body.
Device Description: The device is a material (zirconia blanks) used to create dental restorations. It is not designed to analyze biological samples or provide diagnostic information.
Performance Studies: The performance studies focus on the physical and mechanical properties of the material and the resulting restorations (strength, solubility, color, etc.), not on diagnostic accuracy or performance with biological samples.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

Product codes

EIH

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Anterior and posterior location (dental)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental technicians in dental laboratories

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical data submitted to demonstrate substantial equivalence included:

Mechanical testing for flexural strength, Coefficient of Thermal Expansion (CTE), solubility, radioactivity according to ISO 6872:2015/Amd 1:2018
Color consistency, translucency, shade match
Packaging validation
Biocompatibility

Flexural Strength: The average flexural strength of each worst-case block batch tested yielded results above the 800 MPa minimum. The results demonstrate that the product's flexural strength meets the ISO 6872: 2015/Amd 1:2018 requirement to be classified as a Type II, Class 5 ceramic product.

Coefficient of Thermal Expansion (CTE): Tests performed on the high and low colorant extreme shades yielded CTE results within the specification range of 10-11 x 10-6/ºC and a standard deviation of less than 0.5 x 10-6/ºC. The results met the ISO 6872:2015/Amd 1:2018 CTE requirement.

Solubility: Based on the solubility results from similar products that share the same base powder, approximate yttria content, same series of colorants and method of introduction, it was concluded the solubility is below 100 µg/cm2 limit, meeting the ISO 6872:2015/Amd 1:2018 requirement.

Radioactivity: Since BruxZir® Esthetic is produced entirely from the raw materials, which have been certified to meet the radioactivity requirement of ISO 6872:2015/Amd 1:2018, and the processes through which those powders are transformed into a finished product inherently do not induce radioactivity, BruxZir® Esthetic meets the radioactivity requirement of ISO 6872:2015/Amd 1:2018 without the need for further testing of the finished product.

Color Consistency: A ΔE of less than 2.0 between two coordinates in the CEILAB color space is considered indicative that two shades being perceptibly identical to one another. With the maximum ΔE calculations being made between the minimum and maximum L , a, and b* coordinate constituents within each dataset falling below 2.0, it was concluded that BruxZir® Esthetic conforms to color consistency requirements for and between the batch sizes, block types, and press densities tested.

Translucency: The results show that BruxZir® Esthetic to be more translucent than the reference product; therefore, demonstrating conformance with acceptance criteria for translucency.

Shade Match: Evaluations of sintered and glazed restorations by qualified reviewers against the VITA Classical and Bleach shade guides concluded that BruxZir Esthetic meets shade match requirements for all batch sizes, restoration types, and press densities tested.

Packaging Validation: Per ASTM D4169-14, the shipping unit was tested for manual handling, compressive loads, repetitive shocks from vibration, vertical vibration environments, concentrated impacts and secondary manual handling drops. After the tests, the shipping containers were visually inspected for any damages. It was determined that the GL Singe Unit and GL Bridge Block with their respective packaging, is suitable for use.

Biocompatibility: Biological evaluation within a risk management process was performed in accordance with ISO 10993-1:2018 and ISO 14971:2019. Based on the biocompatibility testing results from similar products, it was determined that there is no biocompatibility concern in regards to yttria concentration, colorants, or organic binders.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Flexural Strength: >800 MPa
Density: >6.05 g/cm³
Coefficient of Thermal Expansion (CTE/25-500°C): 10-11x10-6/°C
Chemical Solubility:

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.

Summary

Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the U.S. Department of Health & Human Services. On the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

January 18, 2022

Prismatik Dentalcraft, Inc. So Park Princical Pregulatory Affirs Specialist 2144 Michelson Drive Irvine, California 96212

Re: K213425

Trade/Device Name: BruxZir Esthetic Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH

Dear So Park:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 17, 2021. Specifically, FDA is updating this SE Letter as an administrative correction. The manufacturing process for the predicate device and subject device were reported incorrectly in the 510(k) Summary.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Michael Adjodha, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-6276, michael.adjodha@fda.hhs.gov.

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

Image /page/1/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

November 17, 2021

Prismatik Dentalcraft, Inc. So Park Princical Pregulatory Affirs Specialist 2144 Michelson Drive Irvine, California 96212

Re: K213425

Trade/Device Name: BruxZir Esthetic Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: October 19, 2021 Received: October 21, 2021

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

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(@tda.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 Ouality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K213425

Device Name BruxZir® Esthetic

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.

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/4/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 inside. The text "PRISMATIK DENTALCRAFT, INC." is on the right side of the logo. The text is in a blue sans-serif font.

510(k) Summary

I. SUBMITTER

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

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

Primary Contact Person: So Hyun Park, Principal Regulatory Affairs Specialist Secondary Contact Person: Herbert Crane, VP RA/QA

November 17, 2021 Date Prepared:

II. DEVICE

Name of Device: BruxZir® Esthetic 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

BruxZir® Shaded (K130924)

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

Image /page/5/Picture/0 description: The image contains the alphanumeric string "K213425". The text is written in a bold, sans-serif font. The background is plain white, providing a stark contrast to the dark text.

Image /page/5/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left side, with the colors of the rainbow arranged in a gradient. To the right of the triangle is the text "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. The text is in a blue sans-serif font.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Attributes	Subject Device	Primary Predicate Device	Comparison
Device Name	BruxZir® Esthetic	BruxZir® Shaded	N/A
510(k)	TBD	K130924	N/A
Regulation	21CFR872.6660	21CFR872.6660	Same
Product Code	EIH	EIH	Same
Classification	Class II	Class II	Same
Manufacturer	Prismatik Dentalcraft, Inc.	Prismatik Dentalcraft, Inc.	Same
Intended Use/
Indications for Use	The device is indicated for
use by dental technicians in
the construction of custom
made all ceramic restorations
for anterior and posterior
location.	The device is indicated for
use by dental technicians in
the construction of custom
made all ceramic restorations
for anterior and posterior
location.	Same
Prescription Device	Yes	Yes	Same
Environment of Use	Dental laboratories	Dental laboratories	Same
Design Characteristic	Chemical
Composition	The main ceramic component
is composed of yttria-
stabilized zirconia. The
different shades have varying
trace colorants as required to
match the desired shades.	The main ceramic component
is composed of yttria-
stabilized zirconia. The
different shades have varying
trace colorants as required to
match the desired shades.	Similar; Different yttria
proportion and different
oxide colorants for the
subject device
	Design	Various sizes and thicknesses	Various sizes and thicknesses	Similar; Different sizes and
thicknesses are offered for
the subject device.
	Principle of
Operation	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. No
color needs to be added
before sintering. The final
target shades are achievable
without additional coloring
steps.	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. No
color needs to be added
before sintering. Basic
staining and glazing
techniques need to be used
after sintering to achieve the
desired final target shades.	Similar; The target shades
are achievable without
additional coloring steps for
the subject device.
	Shades	A1, A2, A3, A3.5, A4, B1,
B2, B3, B4, C1, C2, C3, C4,
D2, D3, D4, White, BL1,BL3	100, 200, 300, 400	Different; Final VITA
shades are achievable
without additional coloring
steps for the subject device.
More shades are offered for
the subject device.
	Final Vita Shades	A1, A2, A3, A3.5, A4, B1,
B2, B3, B4, C1, C2, C3, C4	A1, A2, A3, A3.5, A4, B1,
B2, B3, B4, C1, C2, C3, C4	Similar; More final target
shades are offered for the
	Attributes	Subject Device	Primary Predicate Device	Comparison
Design Characteristic		D2, D3, D4, White, BL1,BL3	D2, D3, D4	subject device.
	Flexural Strength	>800 MPa	>800 MPa	Same
	Density	>6.05 g/cm³	>6.05 g/cm³	Same
	Coefficient of Thermal
Expansion
(CTE/25-500°C)	10-11x10-6/°C	10-11x10-6/°C	Same
	Chemical Solubility