(129 days)
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.
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.
The provided text describes a 510(k) premarket notification for a dental coloring solution, BruxZir GT (Gum Tissue) Color™. The document focuses on establishing substantial equivalence to a predicate device, Zirkonzahn Color Liquid Prettau Aquarell Tissue B (K061851), rather than detailing a specific study to prove the device meets acceptance criteria in the context of diagnostic or screening performance (like an AI/ML device).
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and how ground truth was established is not applicable to this document. These details are typically found in submissions for devices that involve diagnostic accuracy or clinical effectiveness studies, which is not the case for this dental coloring solution.
The document primarily focuses on non-clinical performance data to demonstrate substantial equivalence to the predicate device.
Here's the relevant information that can be extracted, framed as acceptance criteria and reported performance where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate Device/ISO Standards) | Reported Device Performance (BruxZir GT Color™) | Comparison |
|---|---|---|
| Flexural Strength of color treated Zirconia: ≥ 800 MPa | ≥ 800 MPa | Meets |
| Fracture Toughness of color treated Zirconia: ≥ 5.0 MPa · m1/2 | ≥ 5.0 MPa · m1/2 | Meets |
| Solubility of color treated Zirconia: ≤ 100 µg/cm2 | ≤ 100 µg/cm2 | Meets |
| Cytotoxicity: No evidence of cell lysis or toxicity | No evidence of causing cell lysis or toxicity | Meets |
| Sensitization: No reaction | No reaction on the tested subject | Meets |
| Irritation: Non-irritant | Considered a non-irritant | Meets |
| Penetration of coloring solution | Comparability to predicate device demonstrated | Meets |
Note: The "Acceptance Criteria" here are derived from the performance characteristics of the predicate device and relevant ISO standards (ISO 6872:2015, ISO 10993-5:2009, ISO 10993-10:2010), which the subject device aims to meet or exceed to prove substantial equivalence.
2. Sample size used for the test set and the data provenance
Not applicable. This is a non-clinical device comparing physical and biological properties, not a diagnostic device with "test sets" of patient data. The tests were performed on laboratory samples of the material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of expert consensus, is typically for clinical or diagnostic interpretations, which is not relevant for this material.
4. Adjudication method for the test set
Not applicable.
5. 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
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used
The "ground truth" for the material's properties (flexural strength, fracture toughness, solubility, biocompatibility) is established through standardized laboratory testing methods described by ISO standards (ISO 6872:2015, ISO 10993-5:2009, ISO 10993-10:2010).
8. The sample size for the training set
Not applicable. There is no training set as it is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable.
{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)
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."
{3}------------------------------------------------
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 |
| EstablishmentRegistration Number: | 3011649314 |
| Primary Contact Person: | Mythili ReguramanRA/QA Associate |
| Secondary Contact Person: | Herbert SchoenhoeferRA/QA Director(949) 440-2632herbert.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 |
{4}------------------------------------------------
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, bondedrestorations | onlays, bonded dentalrestorations | ||
| Feature | Subject Device | Predicate Device | Comparison |
| Use of device | Applied to green stageproducts prior tosintering | Applied to green stageproducts prior tosintering | 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 ofcolor treated Zirconia | ≥ 800 MPa | ≥ 800 MPa | Same |
| Fracture Toughness ofcolor treated Zirconia | $≥5.0 MPa · m1/2$ | $≥5.0 MPa · m1/2$ | Same |
| Solubility of colortreated Zirconia | $≤100 µg/cm2$ | $≤100 µg/cm2$ | Same |
| Purpose | Inorganic pigment usedto produce the color of asintered zirconia productand is uniformlydispersed throughout thedental restoration. | Inorganic pigment usedto produce the color of asintered zirconia productand is uniformlydispersed throughout thedental restoration. | Same |
| Materials | |||
| BruxZir GT (GumTissue) ColorTM iscomposed of a mixtureof metal salts and bio-pigments. | Colour Liquid PrettauAquarell Tissue B iscomposed of aproprietary mixture ofmetal 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
{5}------------------------------------------------
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.
{6}------------------------------------------------
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. < 0.1%, is greater than that of the subject device, the amounts of iron does not affect substantial equivalence. Moreover, the subject device has passed full biocompatibility testing.
In summary, the main components of the subject device and its predicate are substantially equivalent, and the slight differences in overall chemical composition does not affect the substantial equivalence of the subject when compared to the predicate device.
G. PERFORMANCE DATA
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.
H. CONCLUSION
The documentation submitted in this premarket notification demonstrates that the BruxZir GT (Gum Tissue) Color™ is substantially equivalent to the predicate device.
§ 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.