(134 days)
No
The device description and performance studies focus on the material properties and physical characteristics of the zirconia blocks used for dental restorations, with no mention of AI or ML in the fabrication process or intended use.
No.
The device is used for fabricating dental restorations such as crowns and bridges, which replace missing or damaged tooth structure rather than treating a disease or condition.
No
The device, BruxZir® NOW, is a CAD/CAM block used for fabricating dental restorations (e.g., crowns and bridges), not for diagnosing conditions.
No
The device description clearly states that BruxZir® NOW is a pre-shaded, fully sintered zirconia CAD/CAM block, which is a physical material used for fabricating dental restorations. The performance studies also focus on material properties like flexural strength and solubility, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fabricating dental restorations (crowns and bridges) using CAD/CAM or manual milling machines. This is a manufacturing process for a medical device, not a diagnostic test performed on biological samples.
- Device Description: The device is a material (zirconia block) used to create a physical dental restoration. It does not interact with biological samples for the purpose of diagnosis.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical and material properties of the zirconia block (flexural strength, solubility, shade, biocompatibility, radioactivity, packaging), which are relevant to its use as a dental restorative material, not as a diagnostic tool.
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. BruxZir® NOW is a material used to create a device that is placed in vivo (inside the body) for restorative purposes.
N/A
Intended Use / Indications for Use
BruxZir® 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.
Product codes
EIH
Device Description
BruxZir® NOW is a pre-shaded, fully sintered zirconia CAD/CAM block used for fabricating single-unit or multiple-unit dental restorations. BruxZir® NOW is used for fabricating single-unit dental restorations, while BruxZir® NOW Bridge Block is used for fabricating multiple-unit dental restorations. BruxZir® NOW is available in the following shades: Bleach White, Bleach 1, Bleach 3, and 16 VITA Classical shades (A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4). BruxZir® NOW Bridge Block is available in the following 6 VITA Classical shades: A1, A2, A3, B1, C2, D2. The method of fabricating the restoration is with CAD/CAM milling systems.
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 laboratories or by dental professionals.
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 include:
- Flexural Strength according to ISO 6872:2015/Amd 1:2018
- Solubility according to ISO 6872:2015/Amd 1:2018
- Shade evaluation
- Biocompatibility according to ISO 10993-1:2018
- Radioactivity according to ISO 6872:2015/Amd 1:2018
- Packaging Validation according to ASTM D4169-16
No clinical data is included in this submission.
Flexural strength was tested on the worst-case groups for two types of BruxZir® NOW and BruxZir® NOW Bridge Block. 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 6872:2015/Amd 1:2018.
The worst case was tested for solubility and the measured value was 800 MPa (Type II Class 5 per ISO 6872:2015/Amd 1:2018)
Biocompatibility: Biocompatible per ISO 10993-1
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, there 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.
August 2, 2022
Prismatik Dentalcraft, Inc. So Hyun Park Regulatory Affairs Manager 2144 Michelson Drive Irvine, California 96212
Re: K220816
Trade/Device Name: BruxZir NOW Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: June 2, 2022 Received: June 3, 2022
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 (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
1
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 (OS) 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 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
Indications for Use
510(k) Number (if known) K220816
Device Name BruxZir® NOW
Indications for Use (Describe)
BruxZir® 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) | |
|---|---|
| ------------------------------------------------- | -- |
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/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors, ranging from pink to blue to yellow. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC." in blue text.
510(k) Summary
I. SUMBITTER
Prismatik Dentalcraft, Inc. 2144 Michelson Drive, Irvine, CA 92612, USA
Primary Contact Person: So Hyun Park, Regulatory Affairs Manager, MS Email: so.park(@glidewelldental.com Phone: (949) 863-5479
Secondary Contact Person: Herbert Crane, VP RA/QA Email: Herbert.crane(@glidewelldental.com Phone: (949) 222-3531
Date Prepared: July 19, 2022
II. DEVICE
Name of Device: BruxZir® 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
Primary Predicate Device: Perfit FS Dental Zirconia Fully Sintered Block (K203590) Reference Device: BruxZir® Shaded (K130924)
IV. DEVICE DESCRIPTION
BruxZir® NOW is a pre-shaded, fully sintered zirconia CAD/CAM block used for fabricating single-unit or multiple-unit dental restorations. BruxZir® NOW is used for fabricating single-unit dental restorations, while BruxZir® NOW Bridge Block is used for fabricating multiple-unit dental restorations. BruxZir® NOW is available in the following shades: Bleach White, Bleach 1, Bleach 3, and 16 VITA Classical shades (A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4). BruxZir® NOW Bridge Block is available in the following 6 VITA Classical shades: A1, A2, A3, B1, C2, D2. The method of fabricating the restoration is with CAD/CAM milling systems.
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 sections of different colors, including pink, blue, and yellow. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
INDICATIONS FOR USE V.
BruxZir® 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| | Technological
Characteristics | Subject Device
(K220816) | Predicate Device
(K203590) | Comparison |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | Device Name | BruxZir® NOW | Perfit FS Dental
Zirconia Fully
Sintered Block | N/A |
| | Manufacturer | Prismatik Dentalcraft,
Inc. | Vatech Acucera, Inc. | N/A |
| | Product Code | EIH | EIH | Same |
| | Prescription Device | Yes | Yes | Same |
| | Intended Use | BruxZir® NOW is
intended to be used in
fabrication of dental
restorations such as
crowns and bridges for
the purpose of
restoring chewing
function. | Perfit FS Dental
Zirconia Fully Sintered
Block is intended to be
used in fabrication of
dental restorations such
as crowns and bridges
for the purpose of
restoring chewing
function. | Same |
| Design
Characteristics | Indications for Use | BruxZir® 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. | Perfit FS Dental
Zirconia Fully Sintered
Block is used for dental
restorations using
different CAD/CAM or
manual milling
machines. All blocks
are processed through
dental laboratories or
by dental professionals. | Same except for the
device trade name |
| | Material
Composition | The device is
composed of Yttria-
stabilized zirconia
(YSZ) and pigments to
achieve the desired
shades. | The device is
composed of Yttria-
stabilized zirconia
(YSZ) and pigments to
achieve the desired
shades. | Similar, both the subject
device and the predicate
device are composed of
Yttria- stabilized zirconia
as the primary
component and the |
| Technological
Characteristics | Subject Device
(K220816) | Predicate Device
(K203590) | Comparison | |
| Design | Fully sintered zirconia
block available in
block form in 2 sizes
for single and multiple-
unit restorations | Fully sintered zirconia
block available in block
form in various sizes | desired shades are
achieved by using
different pigments.
Different; The subject
device and the predicate
device are offered in
different shapes and
sizes. | |
| Shades | BruxZir® NOW is
available in the
following shades:
Bleach White, Bleach
1, Bleach 3, and 16
VITA Classical shades
(A1, A2, A3, A3.5, A4,
B1, B2, B3, B4, C1,
C2, C3, C4, D2, D3,
D4). BruxZir® NOW
Bridge Block is
available in the
following 6 VITA
Classical shades: A1,
A2, A3, B1, C2, D2. | There are white
zirconia products
(White) and colored
zirconia products, and
colored zirconia is also
divided into Monolayer
(A1, A2, A3.5, A4, B1,
B2, B3, B4, C1, C2,
C3, C4, D2, D3, D4)
color products, Shade
multi-layer (ML
A1/A2/A3, A1M,
A2M, A3M, A3.5M,
A4M) color
products. | Different; The subject
device and the predicate
device are provided in
different shades. | |
| Flexural
Strength | >800 MPa
Type II Class 5 per
ISO 6872:2015/Amd
1:2018 | ≥ 500 MPa
Type II Class 4 per ISO
6872:2015/Amd 1:2018 | Different; The flexural
strength of the subject
device is >800 MPa,
which is higher than the
flexural strength of the
predicate device. ISO
classification is also
different due to the
difference in flexural
strength. | |
| Biocompatibility | Biocompatible per ISO
10993-1 | Biocompatible per ISO
10993-1 | Same | |
| Solubility |