Who is the manufacturer of BruxZir TintEFX Coloring Liquid?

Prismatik Dentalcraft, Inc. filed the 510(k) submission for BruxZir TintEFX Coloring Liquid (K231347).

What is the FDA product code for BruxZir TintEFX Coloring Liquid?

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 TintEFX Coloring Liquid?

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

Who can help prepare an FDA 510(k) submission like BruxZir TintEFX Coloring Liquid?

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 TintEFX Coloring Liquid

K231347 · Prismatik Dentalcraft, Inc. · EIH · Jun 9, 2023 · Dental

Device Facts

Record ID	K231347
Device Name	BruxZir TintEFX Coloring Liquid
Applicant	Prismatik Dentalcraft, Inc.
Product Code	EIH · Dental
Decision Date	Jun 9, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 872.6660
Device Class	Class 2

Intended Use

BruxZir™ TintEFX Coloring Liquid is used for coloring pre-sintered zirconia structures.

Device Story

BruxZir™ TintEFX Coloring Liquid consists of aqueous solutions containing transition and lanthanide metal salts; used by dental technicians in a laboratory setting to enhance esthetic properties of zirconia restorations. The liquid is applied to pre-sintered zirconia frameworks via dipping or metal-free brush application. Following application, the structure is dried and sintered at temperatures exceeding 1400°C. The device is available in 14 distinct shades to mimic natural tooth color on gingival, body, or incisal parts of the restoration. The output is a colored zirconia restoration, which aids the dental technician in achieving desired esthetic outcomes for the patient.

Clinical Evidence

No clinical data. Bench testing only: flexural strength (>800 MPa), chemical solubility (<100 µg/cm²), visual shade evaluation, shelf life (0.5 years), packaging validation, and biocompatibility (cytotoxicity, skin sensitization, oral mucosal irritation) per ISO 6872:2015/Amd 1:2018 and ISO 10993.

Technological Characteristics

Aqueous solutions of transition and lanthanide metal salts; non-sterile; 175mL bottle packaging. Complies with ISO 6872:2015/Amd 1:2018 for flexural strength and chemical solubility. Biocompatibility per ISO 10993-1, 10993-5, and 10993-10. No software or electronic components.

Indications for Use

Indicated for coloring pre-sintered zirconia structures by dental technicians for the fabrication of dental restorations.

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™ Opaque Coloring Liquid (K220960)

Related Devices

K230262 — BruxZir Incisal Coloring Liquid · Prismatik Dentalcraft, Inc. · May 16, 2023
K220960 — BruxZir Opaque Coloring Liquid · Prismatik Dentalcraft, Inc. · Jun 29, 2022
K190518 — Color Liquid, Vita Liquid · Zirkonzahn Srl · Nov 22, 2019
K220369 — Esthetic Colorant · Kuraray Noritake Dental, Inc. · Sep 23, 2022
K143090 — LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID · Talladium, Inc. · Jun 15, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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. June 9, 2023 Prismatik Dentalcraft, Inc. Nina Chiang Regulatory Affairs Specialist 2144 Michelson Drive Irvine, California 92612 Re: K231347 Trade/Device Name: BruxZir™ TintEFX Coloring Liquid Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 4, 2023 Received: May 9, 2023 Dear Nina Chiang: 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 {1}------------------------------------------------ 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 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, # 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 Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K231347 Device Name BruxZir™ TintEFX Coloring Liquid Indications for Use (Describe) BruxZir™ TintEFX Coloring Liquid is used for coloring pre-sintered zirconia structures. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### 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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ 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, including pink, blue, and yellow. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC." in blue text. ### K231347 ### 510(k) Summary #### SUBMITTER I. Prismatik Dentalcraft, Inc. 2144 Michelson Drive, Irvine, CA 92612, USA Primary Contact Person: Nina Chiang, Regulatory Affairs Specialist Email: nina.chiang@glidewelldental.com Phone: (949) 222-2258 Secondary Contact Person: So Hyun Park, Regulatory Affairs Manager, MS Email: so.park(@glidewelldental.com Phone: (949) 863-5479 Date Prepared: May 04, 2023 #### II. DEVICE Name of Device: BruxZir™ TintEFX Coloring Liquid Common Name or Usual Name: Liquid for Dental Zirconia Prosthesis Classification Name: Porcelain powder for clinical use (21 CFR 872.6660) Regulatory Class: Class II Product Code: EIH #### III. PREDICATE DEVICE BruxZir™ Opaque Coloring Liquid (K220960) #### IV. DEVICE DESCRIPTION BruxZirTM TintEFX Coloring Liquid comprises a set of solutions that enhance the esthetic properties of zirconia restorations. The solution is applied to the zirconia restorations before sintering, by dipping the framework into the liquid or by using a metal-free brush. Afterwards, the structure is dried and subsequently sintered at temperatures above 1400°C. BruxZir™ TintEFX Coloring Liquid is available in 14 different colors, Brown, Green, Blue, Pink, Orange, Purple, Grey, Yellow, G00, G0, G1, G3, G4, and G5. The devices can be used on the gingival part, body part, and/or incisal part of dental restoration to provide esthetic properties and mimic nature tooth color. The devices are intended to be used solely by dental technicians for fabrication of zirconia restorations for individual dental patients. #### V. INDICATIONS FOR USE BruxZir™ TintEFX Coloring Liquid is used for coloring pre-sintered zirconia structures. {4}------------------------------------------------ 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 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. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | Technological Characteristics | Subject Device (K231347) | Predicate Device (K220960) | Comparison | | |--------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Device Name | BruxZir™ TintEFX Coloring Liquid | BruxZir™ Opaque Coloring Liquid | N/A | | | Product Code | EIH | EIH | Same | | | Manufacturer | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | Same | | | Intended Use/ Indications for Use | BruxZir™ TintEFX Coloring Liquid is used for coloring pre- sintered zirconia structures. | BruxZir™ Opaque Coloring Liquid is used for coloring pre- sintered zirconia structures. | Same | | | Prescription Device | Yes | Yes | Same | | | Design Characteristics | Chemical Composition | Aqueous solutions of transition and lanthanide metal salts | Aqueous solutions of transition and lanthanide metal salts | Similar; additional transition and lanthanide metals and nitric acid for the subject device | | | Biocompatibility | Biocompatible | Biocompatible | Same | | | Principle of Operation | Brushing or Dipping Technique | Brushing or Dipping Technique | Same | | | Type of Packaging and Volume | Bottle; 175mL (150mL Volume) | Bottle; 175mL (150mL Volume) | Same | | | Shades | Various; Brown, Green, Blue, Pink, Orange, Purple, Grey, Yellow, G00, G0, G1, G3, G4, and G5 | Various; Opaq-Lite, Opaq-A, Opaq-C, Opaq, Opaq Plus | Different | | | Flexural Strength | >800 MPa | >800 MPa | Same | | | Chemical Solubility | <100 µg/cm² | <100 µg/cm² | Same | | | Visual Shade Evaluation | Pass | Pass | Same | | Sterility | Non-sterile | Non-sterile | Same | | # DETERMINATION OF SUBSTANTIAL EQUIVALENCE The subject device, BruxZir™ TintEFX Coloring Liquid, is substantially equivalent in intended use, material, design principles and performance to the predicate device, BruxZir™ Opaque Coloring Liquid (K220960). The intended use/indications for use {5}------------------------------------------------ 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 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. for both the subject device and the predicate device are the same except for the device name. Both devices are liquids used for coloring pre-sintered zirconia restorations. The fundamental principle of operation of the subject device and the predicate device is the same. The subject device and the predicate device are similar in terms of chemical composition as both devices contain transition and lanthanide metal salts as the major constituents. The differences in terms of chemical composition does not raise any new concerns of safety and effectiveness of the subject device as the performance testing results of the subject device support that the subject device is substantially equivalent to the predicate device. The substantial equivalence comparison table above outlines and provides the similarities between the subject device, BruxZir™ TintEFX Coloring Liquid, and the predicate device, BruxZir™ Opaque Coloring Liquid (K220960). 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 and ISO 10993. #### VII. PERFORMANCE DATA Non-clinical data submitted to demonstrate substantial equivalence included: - Mechanical testing for flexural strength and chemical solubility - Visual shade evaluation - Shelf life ● - Packaging validation ● - Biocompatibility ● No clinical data is included in this submission. # Flexural Strength Flexural strength testing was tested on the zirconia substrate treated with the worst case of the subject device, BruxZir™ TintEFX Coloring Liquid, per ISO 6872:2015/Amd 1:2018. The results demonstrate that the subject device applied to the zirconia substrate satisfies the minimum mechanical properties of zirconia required for Type II, Class 5 per ISO 6872:2015/Amd 1:2018. 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™ TintEFX Coloring Liquid, and the predicate device, BruxZir™ Opaque Coloring Liquid (K220960). # Chemical Solubility Chemical solubility was tested on the worst case. It was concluded that the solubility is below the 100 µg/cm2 limit, 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 device design between the subject device, BruxZir™ TintEFX Coloring Liquid, and the predicate device, BruxZir™ Opaque Coloring Liquid (K220960). # Visual Shade Evaluation The dental restorations were milled from zirconia milling blanks with application of the subject device, BruxZir™ TintEFX Coloring Liquid. Visual shade evaluations Prismatik Dentalcraft, Inc. 510(k) Notification BruxZir™ TintEFX Coloring Liquid {6}------------------------------------------------ Image /page/6/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 several sections, each with a different color. The company name is written in a sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. were performed on the sintered and glazed restorations by qualified reviewers against reference shade guides. It was concluded that BruxZir™ TintEFX Coloring Liquid 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 device design between the subject device, BruxZir™ TintEFX Coloring Liquid, and the predicate device, BruxZir™ Opaque Coloring Liquid (K220960). ### Shelf Life The accelerated aging test was performed per ASTM F1980-21 to establish the shelf life of the subject device, BruxZir™ TintEFX Coloring Liguid. It was concluded that the shelf life of BruxZir™ TintEFX Coloring Liquid is 0.5 years. The results of the testing were used to address questions related to substantial equivalence based on differences in shelf life between the subject device, BruxZir"M TintEFX Coloring Liquid, and the predicate device, BruxZir™ Opaque Coloring Liquid (K220960). ### Packaging Validation Packaging configurations were evaluated to ensure that it is suitable to withstand the distribution environment such that the device packaged in a bottle can be sent to a customer undamaged. The subject device, BruxZir™ TintEFX Coloring Liquid, uses the same packaging materials and packaging configurations as the predicate device, BruxZir™ Opaque Coloring Liquid (K220960). The results of the previous packaging validation were used to address questions related to substantial equivalence based on differences in packaging configuration between the subject device, BruxZir"M TintEFX Coloring Liquid, and the predicate device, BruxZir™ Opaque Coloring Liquid (K220960). ### Biocompatibility The subject device, BruxZir™ TintEFX Coloring Liquid, was tested in accordance with ISO 10993-1. Per the biological evaluation, BruxZir™ TintEFX Coloring Liquid was tested for Cytotoxicity (ISO 10993-5:2009), Skin Sensitization (ISO 10993-10:2021), and Oral Mucosal Irritation (ISO 10993-10:2021) to meet the biocompatibility requirements. Based on the biocompatibility testing results, it was determined that there is no biocompatibility concern for the subject device. 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"M TintEFX Coloring Liquid, and the predicate device. BruxZirTM Opaque Coloring Liquid (K220960). #### VIII. CONCLUSION Based on the technological characteristics and non-clinical test data included in this submission, BruxZirTM TintEFX Coloring Liquid has been shown to be substantially equivalent to the predicate device. BruxZir™ Opaque Coloring Liquid (K220960).