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.

AI/ML Overview

This document describes the premarket notification (510(k)) for the BruxZir® Esthetic device, a dental ceramic material. The focus is on demonstrating its substantial equivalence to a predicate device, which usually involves performance testing against established standards.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Properties:
Flexural Strength: >800 MPa (ISO 6872:2015/Amd 1:2018, Type II, Class 5)	Average flexural strength of each worst-case block batch tested yielded results above 800 MPa minimum.
Density: >6.05 g/cm³	>6.05 g/cm³ (Listed as "Same" with predicate, implying this was met)
Coefficient of Thermal Expansion (CTE/25-500°C): 10-11x10⁻⁶/°C and a standard deviation of less than 0.5 x 10⁻⁶/°C (ISO 6872:2015/Amd 1:2018)	Tests performed on high and low colorant extreme shades yielded CTE results within 10-11 x 10⁻⁶/°C and a standard deviation of less than 0.5 x 10⁻⁶/°C.
Chemical Solubility: <100 µg/cm² (ISO 6872:2015/Amd 1:2018)	Concluded solubility is below 100 µg/cm² limit, based on similar products with same base powder, yttria content, colorants, and method of introduction.
Radioactivity (Uranium-238): No more than 1.0 Bq/g (ISO 6872:2015/Amd 1:2018)	Produced from raw materials certified to meet the radioactivity requirement; processes do not induce radioactivity, therefore meets the requirement.
Biocompatibility: Biocompatible and non-toxic (ISO 10993-1:2018 and ISO 14971:2019)	Concluded no biocompatibility concern based on testing results from similar products.
Aesthetic Properties:
Color Consistency: ΔE of less than 2.0 within a block, within a batch, and between batches (CEILAB color space)	Maximum ΔE calculations between minimum and maximum L, a, and b* coordinate constituents within each dataset falling below 2.0. Conforms to color consistency requirements.
Translucency	Device is more translucent than the reference product, demonstrating conformance with acceptance criteria.
Shade Match: Meets requirements for VITA Classical and Bleach shade guides	Meets shade match requirements for all batch sizes, restoration types, and press densities tested by qualified reviewers.
Packaging:
Packaging Validation (ASTM D4169-14: manual handling, compressive loads, repetitive shocks, vertical vibration, concentrated impacts, secondary manual handling drops)	Shipping containers (GL Single Unit and GL Bridge Block) were visually inspected after tests and determined to be suitable for use.

Study Information:

Sample sizes used for the test set and the data provenance:
- The document does not explicitly state the numerical sample sizes for each test set (e.g., number of blocks tested for flexural strength). It refers to "worst-case group," "high and low colorant extreme shades," "every batch," "each thickness of Zeno block," "each block type pressed from each batch," and "different styles" for packaging.
- Data Provenance: Not explicitly stated, but given it's a FDA submission for a US-based company (Prismatik Dentalcraft, Inc. in Irvine, California), it's highly likely the studies were conducted in the US and were likely prospective in nature, designed specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For "Shade Match" evaluation, it states "Evaluations of sintered and glazed restorations by qualified reviewers." The exact number of reviewers and their specific qualifications (e.g., "radiologist with 10 years of experience") are not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- For the aesthetic evaluations (Color Consistency, Translucency, Shade Match), no specific adjudication method (like 2+1 or 3+1) is mentioned. "Qualified reviewers" determined the shade match, implying subjective evaluation against VITA guides. Other tests were objective measurements against quantitative criteria.
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:
- This is not applicable to this device. The BruxZir® Esthetic is a dental material (zirconia milling block), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance comparison was conducted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable as there is no algorithm or AI component to this device. The performance data is based on physical and chemical testing of the material itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established by objective measurements and adherence to international standards (e.g., ISO 6872:2015/Amd 1:2018 for mechanical and physical properties, ASTM D4169-14 for packaging, ISO 10993-1:2018/ISO 14971:2019 for biocompatibility).
- For the aesthetic properties (color consistency, translucency, shade match), the ground truth is based on quantitative color space measurements (ΔE CEILAB) and qualitative assessments by "qualified reviewers" against established dental shade guides (VITA Classical and Bleach shade guides).
The sample size for the training set:
- This device is a material, not a machine learning model, so there is no training set in the context of AI/ML. All data described are for device performance testing.
How the ground truth for the training set was established:
- As there is no training set for an AI/ML model, this question is not applicable. The "ground truth" for the material's properties is established through the standardized testing methods outlined above.

Summary

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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

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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

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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(@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

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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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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.

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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 foruse by dental technicians inthe construction of custommade all ceramic restorationsfor anterior and posteriorlocation.	The device is indicated foruse by dental technicians inthe construction of custommade all ceramic restorationsfor anterior and posteriorlocation.	Same
Prescription Device	Yes	Yes	Same
Environment of Use	Dental laboratories	Dental laboratories	Same
Design Characteristic	ChemicalComposition	The main ceramic componentis composed of yttria-stabilized zirconia. Thedifferent shades have varyingtrace colorants as required tomatch the desired shades.	The main ceramic componentis composed of yttria-stabilized zirconia. Thedifferent shades have varyingtrace colorants as required tomatch the desired shades.	Similar; Different yttriaproportion and differentoxide colorants for thesubject device
	Design	Various sizes and thicknesses	Various sizes and thicknesses	Similar; Different sizes andthicknesses are offered forthe subject device.
	Principle ofOperation	The manufactured dentalrestorations are madeutilizing a CAD/CAM systemfor design and manufacture.The designed andmanufactured dentalrestorations are then sinteredat a high temperature. Nocolor needs to be addedbefore sintering. The finaltarget shades are achievablewithout additional coloringsteps.	The manufactured dentalrestorations are madeutilizing a CAD/CAM systemfor design and manufacture.The designed andmanufactured dentalrestorations are then sinteredat a high temperature. Nocolor needs to be addedbefore sintering. Basicstaining and glazingtechniques need to be usedafter sintering to achieve thedesired final target shades.	Similar; The target shadesare achievable withoutadditional coloring steps forthe 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 VITAshades are achievablewithout additional coloringsteps for the subject device.More shades are offered forthe 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 targetshades 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 ThermalExpansion(CTE/25-500°C)	10-11x10-6/°C	10-11x10-6/°C	Same
	Chemical Solubility	<100 µg/cm2	<100 µg/cm2	Same
	Radioactivity	The activityconcentration of Uranium-238 is no more than 1.0 Bq/g.	The activityconcentration of Uranium-238 is no more than 1.0 Bq/g.	Same
	Biocompatibility	Biocompatible and non-toxic	Biocompatible and non-toxic	Same
	Sterility	Non-sterile	Non-sterile	Same
	Manufacturing Process	Bi-axial pressing process	Colloidal process	Different manufacturing process

Prismatik Dentalcraft, Inc. 510(k) Notification
BruxZir® Esthetic
October 2021

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K213425

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The subject device, BruxZir® Esthetic, is substantially equivalent in intended use, material, design principles and performance to the primary predicate device, BruxZir® Shaded (K130924). The main components of the subject device, BruxZir® Esthetic, and the predicate device, BruxZir® Shaded (K130924), are substantially equivalent as generic type of material has not been changed and it does not alter the performance specifications of the subject device. The slight differences in overall chemical composition do not affect biocompatibility and performance characteristics.

The fundamental principle of operation of the subject device, BruxZir® Esthetic, and the predicate device, BruxZir® Shaded (K130924), is similar. The difference between the subject device and the predicate device is that the final target shades are achievable without additional coloring steps for the subject device whereas basic staining and glazing techniques are required after sintering in order to achieve the final target shades for the predicate device. Also, the change in the manufacturing process from colloidal process (slip casting) to press process does not affect the mechanical properties of the final finished device.

The substantial equivalence comparison table above outlines and provides the similarities between the subject device, BruxZir® Esthetic, and the predicate device, BruxZir® Shaded (K130924). 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 (Type II, Class 5) and ISO 10993. Any differences between the subject device and the predicate device do not raise any new concerns of safety and effectiveness.

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VII. PERFORMANCE DATA

Non-clinical data submitted to demonstrate substantial equivalence included:

Mechanical testing for flexural strength, Coefficient of Thermal Expansion 0 (CTE), solubility, radioactivity according to ISO 6872:2015/Amd 1:2018
Color consistency, translucency, shade match ●
Packaging validation ●
Biocompatibility o

Flexural Strength

The flexural strength was tested on the worst-case group. 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)

Coefficient of Thermal Expansion (CTE) was tested in order to demonstrate compliance with the ISO 6872:2015/Amd 1:2018 requirement. Tests performed on the high and low colorant extreme shades vielded 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

Color consistency within a block, within a batch and between batches was tested. 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. The results of the testing were used to address questions related to substantial equivalence based on differences in

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device design between the subject device, BruxZir® Esthetic, and the predicate device, BruxZir® Shaded (K130924).

Translucency

Translucency was tested for every batch as well as each thickness of Zeno block pressed. The results show that BruxZir® Esthetic to be more translucent than the reference product; therefore, demonstrating conformance with acceptance criteria for translucency. 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® Esthetic, and the predicate device, BruxZir® Shaded (K130924).

Shade Match

Shade match validation was performed on restorations milled and sintered from each block type pressed from each batch. 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. 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® Esthetic, and the predicate device, BruxZir® Shaded (K130924).

Packaging Validation

Packaging validation was also performed for different styles, GL Single Unit and GL Bridge Block, offered for BruxZir® Esthetic. 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. 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® Esthetic, and the predicate device, BruxZir® Shaded (K130924).

Biocompatibilitv

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. 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® Esthetic, and the predicate device, BruxZir® Shaded (K130924).

VIII. CONCLUSION

BruxZir® Esthetic was evaluated for substantial equivalence using standard and/or comparative testing. Based on technological characteristics and non-clinical test data

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Image /page/9/Picture/0 description: The image contains 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.

included in this submission, BruxZir® Esthetic has been shown to be substantially equivalent to BruxZir® Shaded (K130924).

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.