(129 days)
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No
The summary describes a coloring solution for dental restorations and its performance characteristics, with no mention of AI or ML.
No
The device is a coloring solution for dental restorations, providing aesthetic and efficiency benefits. It does not actively treat or prevent a medical condition, which is characteristic of a therapeutic device.
No
The device is a coloring solution for dental restorations, used to achieve shade consistency and aesthetics. It is not used to diagnose any medical condition.
No
The device description clearly states it is a "coloring solution" that comes in a "150 mL bottle," indicating it is a physical substance, not software. The performance studies also focus on material properties like penetration, solubility, flexural strength, and biocompatibility, which are relevant to a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for coloring dental restorations (crowns, bridges, etc.) to match gum tissue. This is a manufacturing or processing aid for dental prosthetics, not a diagnostic test performed on a biological sample.
- Device Description: The description clearly states it's a "coloring solution" applied to a "green stage restoration before sintering." This further reinforces its role in the fabrication of dental devices.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies focus on the physical properties and biocompatibility of the colored zirconia material, not on diagnostic accuracy or clinical performance in diagnosing a condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
BruxZir GT (Gum Tissue) Color™ is indicated for metal free single posterior crowns, multiple unit anterior crowns/ bridges including full and partial arches, bonded restorations.
Product codes
EIH
Device Description
BruxZir GT (Gum Tissue) Color™ is a coloring solution for the gum tissue (gingival) area of full and partial-arch dental restorations. The product can also be used for crowns and bridges when restoration of the gingival area is included. It provides shade consistency, aesthetics and efficiency when preparing a zirconia restoration. The solution is to be applied to green stage restoration before sintering. The BruxZir GT (Gum Tissue) Color™ comes in a 150 mL bottle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
gum tissue (gingival) area of full and partial-arch dental restorations, crowns and bridges
Indicated Patient Age Range
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Intended User / Care Setting
Dental laboratories
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Prismatik Dentalcraft performed various non-clinical tests and a risk analysis was also conducted to comply with ISO 14971:2012. The test results for the penetration of BruxZir GT (Gum Tissue) Color™ solution, solubility (ISO 6872:2015), the flexural strength (ISO 6872:2015) and fracture toughness (ISO 6872:2015) indicate that BruxZir GT (Gum Tisue) Color™ is comparable to the predicate device. In addition, BruxZir GT (Gum Tissue) Color™ has also been tested for Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010) and Irritation (ISO 10993-10:2010) to meet the biocompatibility requirement and the results are as follows:
- The Cytotoxicity Report shows that there was no evidence of causing cell lysis or toxicity.
- The Sensitization Report shows that there was no reaction on the tested subject.
- The Irritation Report shows that the test article was considered a nonirritant.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
November 22, 2019
Prismatik Dentalcraft, Inc. Mythili Reguraman RA/OA Associate 2212 Dupont Dr. Irvine, California 92612
Re: K191903
Trade/Device Name: BruxZir GT (Gum Tissue) Color™ Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: August 19, 2019 Received: August 26, 2019
Dear Mythili Reguraman:
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
1
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,
for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental 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
Indications for Use
510(k) Number (if known) K191903
Device Name BruxZir GT (Gum Tissue) Color™
Indications for Use (Describe)
BruxZir GT (Gum Tissue) Color™ is indicated for metal free single posterior crowns, multiple unit anterior crowns/ bridges including full and partial arches, bonded restorations.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over The Counter Use (21 CFR 801) |
|---|---|
| ---------------------------------------------- | ----------------------------------- |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
|__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with a rainbow gradient. To the right of the prism is the company name, "PRISMATIK DENTALCRAFT, INC." in blue text.
510(k) Summary
SUBMITTER INFORMATION A.
B.
| Company Name: | Prismatik Dentalcraft, Inc. |
|---|---|
| Company Address: | 2212 Dupont Dr. |
| Irvine, CA 92612 | |
| Company Phone: | (949) 440-2678 |
| Company Fax: | (949) 553-0924 |
| Establishment | |
| Registration Number: | 3011649314 |
| Primary Contact Person: | Mythili Reguraman |
| RA/QA Associate | |
| Secondary Contact Person: | Herbert Schoenhoefer |
| RA/QA Director | |
| (949) 440-2632 | |
| herbert.schoenhoefer@glidewelldental.com | |
| Date Summary Prepared: | November 20th, 2019 |
| DEVICE IDENTIFICATION | |
| Trade/Proprietary Name: | BruxZir GT (Gum Tissue) Color™ |
| Common Name: | Gum Tissue colorant |
| Classification Name: | Porcelain powder for clinical use |
| Regulation Number: | 21 CFR 872.6660 |
| Product Code: | EIH |
| Device Class: | 2 |
| Review Panel: | Dental |
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Image /page/4/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors, including pink, purple, blue, green, yellow, and orange. To the right of the triangle is the text "PRISMATIK" in a larger font, with "DENTALCRAFT, INC." below it in a smaller font. The text is in a blue color.
C. IDENTIFICATION OF PREDICATE DEVICE
Predicate: Zirkonzahn Color Liquid Prettau Aquarell Tissue B (K061851)
D. DEVICE DESCRIPTION
BruxZir GT (Gum Tissue) Color™ is a coloring solution for the gum tissue (gingival) area of full and partial-arch dental restorations. The product can also be used for crowns and bridges when restoration of the gingival area is included. It provides shade consistency, aesthetics and efficiency when preparing a zirconia restoration. The solution is to be applied to green stage restoration before sintering. The BruxZir GT (Gum Tissue) Color™ comes in a 150 mL bottle.
E. INDICATIONS FOR USE
BruxZir GT (Gum Tissue) Color™ is indicated for metal-free single posterior crowns, multiple-unit anterior crowns/bridges including full and partial arches, bonded restorations.
F. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Refer to the Comparison Table below showing similarities and differences between the predicate device and subject device.
| Feature | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Trade Name | BruxZir GT (Gum Tissue) Color™ | Zirkonzahn Color Liquid Prettau Aquarell Tissue B | |
| 510(k) | K191903 | K061851 | |
| Regulation | 21 CFR 872.6660 | 21 CFR 872.6660 | Same |
| Product Code | EIH | EIH | Same |
| Classification | II | II | Same |
| GMDN Code | 17844 | 17844 | Same |
| GMDN Preferred Term | Dental Articulation Liquid | Dental Articulation Liquid | Same |
| Indications for Use | Metal free single posterior crowns, multiple unit anterior crowns/bridges including full and | Metal free single posterior crowns, multiple unit anterior crowns/bridges, inlays, | Similar |
| partial arches, bonded | |||
| restorations | onlays, bonded dental | ||
| restorations | |||
| Feature | Subject Device | Predicate Device | Comparison |
| Use of device | Applied to green stage | ||
| products prior to | |||
| sintering | Applied to green stage | ||
| products prior to | |||
| sintering | Same | ||
| Prescription Device | Yes | Yes | Same |
| Contraindication | None | None | Same |
| Environment of Use | Dental laboratories | Dental laboratories | Same |
| Design | |||
| Shade | Pink | Pink | Same |
| Flexural Strength of | |||
| color treated Zirconia | ≥ 800 MPa | ≥ 800 MPa | Same |
| Fracture Toughness of | |||
| color treated Zirconia | $≥5.0 MPa · m1/2$ | $≥5.0 MPa · m1/2$ | Same |
| Solubility of color | |||
| treated Zirconia | $≤100 µg/cm2$ | $≤100 µg/cm2$ | Same |
| Purpose | Inorganic pigment used | ||
| to produce the color of a | |||
| sintered zirconia product | |||
| and is uniformly | |||
| dispersed throughout the | |||
| dental restoration. | Inorganic pigment used | ||
| to produce the color of a | |||
| sintered zirconia product | |||
| and is uniformly | |||
| dispersed throughout the | |||
| dental restoration. | Same | ||
| Materials | |||
| BruxZir GT (Gum | |||
| Tissue) ColorTM is | |||
| composed of a mixture | |||
| of metal salts and bio- | |||
| pigments. | Colour Liquid Prettau | ||
| Aquarell Tissue B is | |||
| composed of a | |||
| proprietary mixture of | |||
| metal salts and bio- | |||
| pigments. | Similar | ||
| Biocompatibility | Biocompatible and non--toxic | Biocompatible and non--toxic | Same |
| Sterility | Provided Non-Sterile | Provided Non- Sterile | Same |
Table 8-1 - Comparison between Predicate device and Subject device
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Image /page/5/Picture/1 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangle with a gradient of colors, including pink, red, blue, green, and yellow. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." The text is in a sans-serif font and is blue.
The indication for use of Zirkonzahn states that it can be used for single posterior crowns, multiple unit anterior crowns/bridges, inlays, onlays and bonded restorations. For Bruxzir GT (Gum Tissue) Color™ solution, the indications for use is similar and can be used on single posterior crowns, multiple unit anterior crowns/bridges including full and partial arches as well as bonded restorations. The 510(k) for Zirkonzhan Color Liquid Prettau Aquarell Tissue B (K061851) also covered Zirkonzahn Ice, therefore their indications for use included inlays and onlays. The minor difference in use is justified by the fact that BruxZir GT (Gum Tissue) Color™ is intended for the gingival areas and therefore would not be used for inlays or onlays since these restorations do not include the gingival area.
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Image /page/6/Picture/1 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangle with a color gradient. The colors in the triangle range from blue to green to yellow to pink. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font.
Zirkonzahn Color Liquid Prettau Aquarell Tissue B (K061851) coloring solution contains red colorants while BruxZir GT (Gum Tissue) Color™ solution uses green food coloring solution. The sintering process exposes the food coloring components to temperatures much higher than their decomposition temperature for extended times, all of the components will completely decompose.
Although the amount of iron present in the predicate device.