(31 days)
Not Found
No
The device description and performance studies focus on the chemical and mechanical properties of a coloring liquid for dental restorations, with no mention of AI or ML.
No
The device is described as a coloring liquid for pre-sintered zirconia structures, used to enhance esthetic properties and mimic natural tooth color for dental restorations. It does not treat or cure any medical condition.
No
This device is described as a coloring liquid used to enhance the aesthetic properties of dental restorations and does not perform any diagnostic function.
No
The device is a liquid solution used for coloring zirconia structures, which is a physical substance and not software.
Based on the provided information, the BruxZir™ TintEFX Coloring Liquid is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "coloring pre-sintered zirconia structures" to enhance the esthetic properties of dental restorations. This is a manufacturing process for a dental prosthetic, not a diagnostic test performed on a biological sample.
- Device Description: The description details a set of solutions applied to zirconia before sintering to achieve desired colors. This is a material used in the fabrication of a medical device (dental restoration), not a test or assay.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose, monitor, or treat any disease or condition by examining biological samples (blood, urine, tissue, etc.).
- Intended User: The intended users are "dental technicians for fabrication of zirconia restorations," not healthcare professionals performing diagnostic tests.
- Performance Studies: The performance studies focus on the physical and chemical properties of the colored zirconia (flexural strength, solubility, shade evaluation, shelf life, biocompatibility), which are relevant to the material's use in a dental restoration, not its diagnostic capabilities.
In summary, the BruxZir™ TintEFX Coloring Liquid is a material used in the manufacturing of dental restorations for aesthetic purposes. It does not fit the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
BruxZir™ TintEFX Coloring Liquid is used for coloring pre-sintered zirconia structures.
Product codes (comma separated list FDA assigned to the subject device)
EIH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental technicians
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 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.
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.
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 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.
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.
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).
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength: >800 MPa
Chemical Solubility:
§ 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.
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)
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 |