Who is the manufacturer of BruxZir Esthetic?

Prismatik Dentalcraft, Inc. filed the 510(k) submission for BruxZir Esthetic (K213425).

What is the FDA product code for BruxZir Esthetic?

EIH. It is classified under 21 CFR 872.6660 as a Class 2 device in the Dental panel.

What is the regulatory pathway for BruxZir Esthetic?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like BruxZir Esthetic?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BruxZir Esthetic

K213425 · Prismatik Dentalcraft, Inc. · EIH · Nov 17, 2021 · Dental

Device Facts

Record ID	K213425
Device Name	BruxZir Esthetic
Applicant	Prismatik Dentalcraft, Inc.
Product Code	EIH · Dental
Decision Date	Nov 17, 2021
Decision	SESE
Submission Type	Special
Regulation	21 CFR 872.6660
Device Class	Class 2

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 Story

BruxZir Esthetic is a zirconia milling blank used by dental technicians in laboratories to produce custom all-ceramic dental restorations. The device is processed via CAD/CAM systems for design and milling, followed by high-temperature sintering. Unlike the predicate, which requires post-sintering staining and glazing to achieve target shades, BruxZir Esthetic is pre-shaded, allowing final target shades to be achieved without additional coloring steps. The device is intended for use in all regions of the mouth. The output is a finished dental restoration that restores patient dentition, providing high strength and esthetics.

Clinical Evidence

Bench testing only. Performance validated against ISO 6872:2015/Amd 1:2018 for flexural strength (>800 MPa), CTE (10-11x10^-6/°C), chemical solubility (<100 µg/cm²), and radioactivity. Color consistency (ΔE < 2.0) and translucency confirmed. Shade match validated against VITA Classical and Bleach guides. Packaging validated per ASTM D4169-14. Biocompatibility assessed per ISO 10993-1:2018 and ISO 14971:2019.

Technological Characteristics

Yttria-stabilized zirconia ceramic milling blanks. Manufacturing: bi-axial pressing. Properties: flexural strength >800 MPa, density >6.05 g/cm³, CTE 10-11x10^-6/°C, chemical solubility <100 µg/cm². Non-sterile. Complies with ISO 6872:2015/Amd 1:2018 (Type II, Class 5) and ISO 10993.

Indications for Use

Indicated for use by dental technicians to construct custom all-ceramic restorations for anterior and posterior locations.

Regulatory Classification

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.

Predicate Devices

BruxZir® Shaded (K130924)

Related Devices

K240882 — BruxZir® Esthetic · Prismatik Dentalcraft, Inc. · May 1, 2024
K240574 — BruxZir® Radiant · Prismatik Dentalcraft, Inc. · Mar 20, 2024
K254283 — BruxZir® Shaded 16 PLUS · Prismatik Dentalcraft, Inc. · Jan 30, 2026
K221242 — Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank · Hunan Vsmile Biotechnology Co., Ltd. · Jul 29, 2022
K250223 — BruxZir® Esthetic NOW · Prismatik Dentalcraft, Inc. · Feb 25, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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 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. #### 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. {5}------------------------------------------------ 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 | <100 µg/cm2 | <100 µg/cm2 | Same | | | Radioactivity | The activity concentration of Uranium- 238 is no more than 1.0 Bq/g. | The activity concentration 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 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a color wheel inside. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC." in blue font. ### 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. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors from blue to pink. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC." in blue font. #### 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 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with a color gradient. The text "PRISMATIK DENTALCRAFT, INC." is on the right in blue. 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 {9}------------------------------------------------ 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).