(29 days)
BruxZir® Esthetic NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
BruxZir® Esthetic NOW is a chairside zirconia material offering enhanced esthetic performance. These pre-shaded, fully sintered zirconia CAD/CAM blocks are used by dentists in the construction of custom-made dental restorations that require no sintering, staining, glazing or polishing.
The provided text describes the regulatory submission for a dental material (BruxZir® Esthetic NOW) and its comparison to a predicate device. It includes performance data, but NOT information typically associated with AI/ML device studies, such as sample sizes for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
Therefore, the response will focus on the available information regarding acceptance criteria and the study that proves the device meets those criteria, highlighting the lack of AI/ML-specific details where applicable.
Here's a summary of the acceptance criteria and study findings based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (BruxZir® Esthetic NOW) |
|---|---|
| Flexural Strength: >800 MPa (Type II Class 5 per ISO 6872:2024) | Average flexural strength of worst-case shades was above the minimum threshold of 800 MPa (meeting ISO 6872:2024 for Type II Class 5 ceramic). |
| Chemical Solubility: <100 µg/cm² (ISO 6872:2024) | Measured values for worst cases were <100 µg/cm² (meeting ISO 6872:2024 requirement). |
| Coefficient of Thermal Expansion (CTE): 10-11 x 10-6/°C with standard deviation no greater than 0.5 x 10-6/°C (ISO 6872:2024) | Measured values for worst cases were between 10-11 x 10-6/°C and a standard deviation of CTE no greater than 0.5 x 10-6/°C (meeting ISO 6872:2024 requirement). |
| Shade Evaluation: Meets shade match requirements (Implied by comparison to VITA Classical and reference Bleach shade guides) | Evaluations concluded that BruxZir® Esthetic NOW meets shade match requirements and works as intended. |
| Biocompatibility: Biocompatible (per ISO 10993-1:2018; no biocompatibility concern) | Cytotoxicity testing results determined no biocompatibility concern regarding yttria concentration, colorants, or other elements. |
| Radioactivity: Uranium-238 activity concentration no more than 1.0 Bq/g (ISO 6872:2024) | Measured values for worst cases were below the Uranium-238 activity threshold of 1.0 Bq/g (meeting ISO 6872:2024 requirement). |
| Packaging Validation: Suitable to withstand distribution environment (per ASTM D4169-22) | After testing per ASTM D4169-22, it was determined that the respective packaging for BruxZir® Esthetic NOW blocks is suitable for use. |
2. Sample size used for the test set and the data provenance
The document specifies "worst-case shades" for Flexural Strength, Chemical Solubility, CTE, and Radioactivity testing, and "all shades offered" for Shade Evaluation. However, the exact numerical sample sizes for these tests (e.g., number of blocks tested per shade) are not provided.
The data provenance is from non-clinical testing conducted by the manufacturer, Prismatik Dentalcraft, Inc. No information regarding country of origin of data or whether it was retrospective/prospective is specified, as these are material property tests rather than clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For "Shade evaluation," the document states "qualified evaluators." However, the number of experts and their specific qualifications are not provided. For other non-clinical tests (Flexural Strength, Solubility, CTE, Radioactivity, Biocompatibility, Packaging Validation), ground truth is established by standardized testing methods (e.g., ISO, ASTM) and material science principles, not typically by expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This information is relevant for studies involving human interpretation or subjective assessment with consensus mechanisms, typically in clinical trials or image assessment studies. The described tests are objective material property measurements.
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 device is a dental material (zirconia milling block), not an AI/ML-based diagnostic or assistive device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As this is not an AI/ML device, this type of study is irrelevant.
7. The type of ground truth used
The ground truth for the performance criteria is established by:
- Standardized measurement thresholds: Specific values defined by international standards (ISO 6872:2024, ISO 10993-1:2018, ASTM D4169-22) for material properties (Flexural Strength, Chemical Solubility, CTE, Radioactivity) and biocompatibility.
- Visual comparison: For shade evaluation, it relied on comparison against VITA Classical shade guides and reference Bleach shade guides by qualified evaluators.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set mentioned or implied.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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February 25, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name.
Prismatik Dentalcraft, Inc. So Hyun Park Regulatory Affairs Manager 2144 Michelson Drive Irvine, California 92612
Re: K250223
Trade/Device Name: BruxZir® Esthetic NOW Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: January 24, 2025 Received: January 27, 2025
Dear So Hyun 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Bobak Shirmohamma di -S
For Michael E. Adjodha, M.ChE, RAC, CQIA 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
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Indications for Use
Submission Number (if known)
Device Name
BruxZir® Esthetic NOW
Indications for Use (Describe)
BruxZir® Esthetic NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
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)
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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 a black border. The inside of the triangle is filled with a gradient of colors, including pink, red, yellow, green, blue, and purple. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font.
K250223
510(k) Summary
I. SUBMITTER
Prismatik Dentalcraft, Inc. 2144 Michelson Drive, Irvine, CA 92612, USA
Primary Contact Person: So Hyun Park, Regulatory Affairs Manager Email: so.park(@glidewelldental.com Phone: (949) 863-5479
Secondary Contact Person: Maria Wagner, Sr, Regulatory Affairs Manager Email: maria.wagner@glidewelldental.com Phone: (949) 838-1321
Date Prepared: January 24, 2025
II. DEVICE
| Name of Device: | BruxZir® Esthetic NOW |
|---|---|
| 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® NOW (K220816)
IV. DEVICE DESCRIPTION
BruxZir® Esthetic NOW is a chairside zirconia material offering enhanced esthetic performance. These pre-shaded, fully sintered zirconia CAD/CAM blocks are used by dentists in the construction of custom-made dental restorations that require no sintering, staining, glazing or polishing.
INDICATIONS FOR USE V.
BruxZir® Esthetic NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
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Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle with a gradient of colors on the left side. The text "PRISMATIK DENTALCRAFT, INC." is on the right side of the triangle. The text is in a sans-serif font and is blue.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| TechnologicalCharacteristics | Subject Device(K250223) | Predicate Device(K220816) | Comparison | |
|---|---|---|---|---|
| Device Name | BruxZir® Esthetic NOW | BruxZir® NOW | N/A | |
| Manufacturer | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | Same | |
| Product Code | EIH | EIH | Same | |
| Prescription Device | Yes | Yes | Same | |
| Intended Use | BruxZir® Esthetic NOWis intended to be used infabrication of dentalrestorations such ascrowns for the purposeof restoring chewingfunction. | BruxZir® NOW isintended to be used infabrication of dentalrestorations such ascrowns and bridges forthe purpose of restoringchewing function. | Similar; Due to thedevice design, thesubject device canonly be fabricated intoa single-unitrestoration. | |
| Indications for Use | BruxZir® Esthetic NOWis used for dentalrestorations usingdifferent CAD/CAM ormanual millingmachines. All blocks areprocessed through dentallaboratories or by dentalprofessionals. | BruxZir® NOW is usedfor dental restorationsusing differentCAD/CAM or manualmilling machines. Allblocks are processedthrough dentallaboratories or by dentalprofessionals. | Same except for thedevice trade name | |
| MaterialComposition | The device is composedof Yttria-stabilizedzirconia (YSZ) andpigments to achieve thedesired shades. | The device is composedof Yttria-stabilizedzirconia (YSZ) andpigments to achieve thedesired shades. | Similar; Both thesubject device and thepredicate device arecomposed of Yttria-stabilized zirconia asthe primarycomponent and thedesired shades areachieved by usingdifferent pigments. | |
| DesignCharacteristics | Fully sintered zirconiablock available in blockform in 2 sizes forsingle-unit restoration(anterior and posteriorgeometries) | Fully sintered zirconiablock available in blockform in 2 sizes for singleand multiple-unitrestorations | Similar; Due to thedevice design, thesubject device canonly be fabricated intoa single-unitrestoration. | |
| Shades | BruxZir® Esthetic NOWis available in thefollowing shades: BleachWhite, Bleach 1 and 16 | BruxZir® NOW isavailable in thefollowing shades:Bleach White, Bleach 1 | Similar; The subjectdevice and thepredicate device areoffered in Bleach | |
| TechnologicalCharacteristics | Subject Device(TBD) | Predicate Device(K220816) | Comparison | |
| VITA Classical Shades(A1, A2, A3, A3.5, A4,B1, B2, B3, B4, C1, C2,C3, C4, D2, D3, D4) | Bleach 3, and 16 VITAClassical shades (A1,A2, A3, A3.5, A4, B1,B2, B3, B4, C1, C2, C3,C4, D2, D3, D4).BruxZir® NOW BridgeBlock is available in thefollowing 6 VITAClassical shades: A1, | shades and 16 VITAClassical shades. Thesubject device is notoffered in Bleach 3shade. | ||
| A2, A3, B1, C2, D2. | ||||
| FlexuralStrength | >800 MPaType II Class 5 per ISO6872:2024 | >800 MPa Type II Class5 per ISO6872:2015/Amd 1:2018 | Same | |
| Biocompatibility | Biocompatible perISO 10993-1 | Biocompatible perISO 10993-1 | Same | |
| Solubility | <100 µg/cm² | <100 µg/cm² | Same | |
| Radioactivity | The activityconcentration ofUranium-238 is no morethan 1.0 Bq/g. | The activityconcentration ofUranium-238 is no morethan 1.0 Bq/g. | Same |
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Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a color gradient that starts with pink at the top, transitions to yellow and green in the middle, and ends with blue at the bottom. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC.", written in a sans-serif font and colored in blue.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The subject device, BruxZir® Esthetic NOW, is substantially equivalent to the predicate device, BruxZir® NOW (K220816), in intended use, indications for use, material, design principles and technological characteristics.
The subject device, BruxZir® Esthetic NOW, has similar intended use as the predicate device, BruxZir® NOW (K220816), as the device is used in fabrication of dental restorations such as crowns for the purpose of restoring function. Due to the device design, the subject device, BruxZir® Esthetic NOW, can only be fabricated into a singleunit restoration. The subject device, BruxZir® Esthetic NOW, has the same indications for use statement (IFUS) as the predicate device, BruxZir® NOW (K220816), except for the device trade name. Both the subject device and the predicate device are dental restorative materials indicated for fabrication of dental restorations using CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
The subject device. BruxZir® Esthetic NOW, is substantially equivalent to the predicate device, BruxZir® NOW (K220816), in technological characteristics. The same mechanical property testing in terms of flexural strength that was conducted on the predicate device, BruxZir® NOW (K220816), was also conducted on the subject device, BruxZir® Esthetic NOW, according to ISO 6872:2024. The flexural strength of the subject device, BruxZir®
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Image /page/7/Picture/0 description: The image shows the logo for PRISMATIK DENTALCRAFT, INC. On the left side of the logo is a triangle with different colors. The colors are arranged in a radial pattern, with the colors changing from blue to pink. On the right side of the logo is the text "PRISMATIK DENTALCRAFT, INC.", which is written in blue.
Esthetic NOW, passed the threshold of performance criteria in ISO 6872 for Type II Class న్.
The subject device, BruxZir® Esthetic NOW, and the predicate device, BruxZir® NOW (K220816), are similar in material composition. Both devices utilize Yttria-stabilized zirconia as the base material and pigments. Despite the differences in the pigments used to achieve the desired shades, the slight differences in chemical formulation do not affect the safety and effectiveness of the device as verified and validated by the biocompatibility and performance testing.
The subject device, BruxZir® Esthetic NOW, and the predicate device, BruxZir® NOW (K220816), are substantially equivalent in terms of design. Both are offered in a fully sintered block form in different shapes and shades and are used to make final dental restorations based on the anatomical rendering of the patient's teeth using CAD/CAM equipment.
VII. PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence include:
- Flexural Strength according to ISO 6872:2024 ●
- Chemical Solubility according to ISO 6872:2024 ●
- Coefficient of Thermal Expansion (CTE) according to ISO 6872:2024
- Shade evaluation
- Biocompatibility according to ISO 10993-1:2018
- Radioactivity according to ISO 6872:2024 ●
- Packaging Validation according to ASTM D4169-22 ●
No clinical data is included in this submission.
Flexural Strength
Flexural strength was tested on the worst-case shades and additional shade for BruxZir® Esthetic NOW. The average flexural strength of each worst-case yielded the results above the minimum threshold of 800 MPa, which is the value to be achieved for Type II Class 5 ceramic product according to ISO 6872:2024. The results of the testing were used to address questions related to substantial equivalence based on differences in technical specifications between the subject device, BruxZir® Esthetic NOW, and predicate device, BruxZir® NOW (K220816).
Chemical Solubility
The worst cases of BruxZir® Esthetic NOW were tested for solubility and the measured values were <100 ug/cm2 meeting the ISO 6872:2024 requirement. The result of the testing was used to address questions related to substantial equivalence based on differences in technical specifications between the subject device. BruxZir® Esthetic NOW, and predicate device, BruxZir® NOW (K220816).
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Image /page/8/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 sections of different colors, including pink, red, yellow, green, and blue. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
Coefficient of Thermal Expansion (CTE)
The worst cases of BruxZir® Esthetic NOW were tested for Coefficient of Thermal Expansion and the measured values were between 10-11 x 10-99C and a standard deviation of CTE no greater than 0.5 x 10-9C meeting the ISO 6872:2024 requirement. The result of the testing was used to address questions related to substantial equivalence based on differences in technical specifications between the subject device, BruxZir® Esthetic NOW, and predicate device, BruxZir® NOW (K220816).
Shade Evaluation
All shades offered for BruxZir® Esthetic NOW were evaluated by the qualified evaluators using the sample dental restorations milled from the final sintered products against the corresponding VITA Classical shade guide and reference Bleach shade guide. Evaluations concluded that BruxZir® Esthetic NOW 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 technical specifications between the subject device, BruxZir® Esthetic NOW, and predicate device, BruxZir® NOW (K220816).
Biocompatibility
Biological evaluation within a risk management process was performed in accordance with ISO 10993-1:2018 and ISO 14971:2019. Based on the cytotoxicity testing results from the subject device, BruxZir® Esthetic NOW, it was determined that there is no biocompatibility concern regarding yttria concentration, colorants, or other elements. 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 NOW, and the predicate device, BruxZir® NOW (K220816).
Radioactivity
The worst cases of BruxZir® Esthetic NOW were tested for radioactivity and the measured values were below the Uranium-238 activity threshold of 1.0 Bq g - set by the ISO 6872:2024 requirement. The result of the testing was used to address questions related to substantial equivalence based on differences in technical specifications between the subject device, BruxZir® Esthetic NOW, and predicate device, BruxZir® NOW (K220816).
Packaging Validation
The packaging validation was conducted to ensure that the packaging configurations for BruxZir® Esthetic NOW are suitable to withstand the distribution environment. Per ASTM D4169-22, BruxZir® Esthetic NOW was tested to check resistance against manual handling, vehicle stacking, loose load vibration, low pressure (high altitude) hazard, vehicle vibration, and concentrated impact. After the test, the shipping containers were visually inspected for any damage. It was determined that the respective packaging for BruxZir® Esthetic NOW blocks is suitable for use. The results of the testing were used to address questions related to substantial equivalence based on differences in product packaging
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Image /page/9/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangle with a color gradient. The text "PRISMATIK DENTALCRAFT, INC." is on the right side of the logo in blue.
between the subject device, BruxZir® Esthetic NOW, and predicate device, BruxZir® NOW (K220816).
VIII. CONCLUSION
Based on the technological characteristics and non-clinical test data included in this submission, the subject device, BruxZir® Esthetic NOW, has been shown to be substantially equivalent to the predicate device, BruxZir® NOW (K220816).
§ 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.