(43 days)
Not Found
No
The summary describes a material (zirconia blanks) used for dental restorations and mentions standard biocompatibility and performance testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
No.
The device is used by dental technicians to construct dental restorations, not to directly treat a medical condition.
No
The device is used for constructing custom-made ceramic restorations, not for diagnosing medical conditions.
No
The device description clearly states it is a physical product (zirconia blanks) used for milling dental restorations, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used by dental technicians to construct custom-made dental restorations (crowns and bridges). This is a manufacturing process for a medical device that will be implanted or placed in a patient's mouth.
- Device Description: The device is a material (zirconia blanks) used for milling dental prosthetics.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test a sample from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide diagnostic information. This device is a material used in the creation of a dental prosthetic, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
BruxZir® Shaded Blanks are used for the production of full-contour zirconia and zirconia-based substructures for crowns and bridges. Four (4) thicknesses (12 mm, 15 mm, 20 mm, 25 mm) and four (4) shades (100, 200, 300, 400) are available for milling into BruxZir full-contour crowns and substructures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior location (dental)
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)
Applicable testing was performed in accordance with the Design Verification Plan including a Risk Analysis addressing the impact of changes to the device. The test results indicate the Prismatik BruxZir® Shaded Blank is comparable to the predicate device.
Biocompatibility testing included:
- The Cytotoxicity Report shows that there was no reaction on any of the cells.
- The Sensitization Report shows that there was no reaction on the tested subject.
- The Irritation Report shows that there was no erythema or edema on the test subject.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cytotoxicity Study using the IX MEM extraction method at 37°C - Pass
ISO Intracutaneous Study, Extract 0.9% sodium chloride USP solution (SC) and sesame oil, NF (SO) - Pass
Irritation and Skin Sensitization Study, Extract 0.9% sodium chloride USP and sesame oil, NF (SO) - Pass
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Prismatik™ Clinical Zirconia (Prismatik™ CZ)-K060104
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
B.
C.
Trade/Proprietary Name:
Page 24 of 142
MAY 1 6 2013
006-510 (K) Summary-807.92(c)
This 510 (K) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
SUBMITTER INFORMATION A.
| Company Name: | Prismatik Dentalcraft, Inc. |
|---|---|
| Company Address: | 2212 Dupont Dr., Suite IJK, |
| Irvine, CA 92612 | |
| Company Phone: | 949-225-1269 |
| Company FAX: | 949-553-0924 |
| Facility Registration Number: | 3005477956 |
| Primary Contact Person: | Armin Zehtabchi, (949) 225-1234 |
| Senior RA Specialist | |
| Secondary Contact Person | Marilyn Pourazar, (949) 225-1269 |
| Senior Director, RA/QA | |
| Date Summary Prepared: | April 12, 2013 |
| DEVICE IDENTIFICATION | |
| Trade/Proprietary Name: | BruxZir® Shaded |
| 21 CFR Reference: | 21 CFR 872.6660 |
| 21 CFR Common Name: | Porcelain powder for clinical use |
| Classification: | Class II |
| Panel: | Dental |
| IDENTIFICATION OF PREDICATE DEVICE |
Prismatik™ Clinical Zirconia (Prismatik™ CZ)-K060104
1
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DEVICE DESCRIPTION D.
BruxZir® Shaded Blanks are used for the production of full-contour zirconia and zirconia-based substructures for crowns and bridges. Four (4) thicknesses (12 mm, 15 mm, 20 mm, 25 mm) and four (4) shades (100, 200, 300, 400) are available for milling into BruxZir full-contour crowns and substructures.
E. DEVICE MANUFACTURING PROCESS:
BruxZir® Shaded are manufactured using a colloidal processing without mechanical pressing or the use of organic binders which lead to decreased esthetics. Other dental Zirconia materials on the market today use organic binders to hold the powder together during the high pressure pressing to form the milling blanks. Conversely, BruxZir®'s colloidal process utilizes vacuum slip casting to form the blocks. This process creates a block with superior microstructure and homogeneity when compared to pressed blocks.
Vacuum slip casting is a ceramic forming technique which uses ceramic slip and a porous mold made from Plaster of Paris. The ceramic powder consolidates and accumulates on the top of the porous mold while the water is absorbed into it, thus forming a high density green state block. One of the several advantages for the colloidal process employed in the creation of BruxZir® products is that smaller particles dispersed using TMAOH and are compacted homogenously through the colloidal process. This results in a material that has a higher translucency value. This allows the end product to have a closer appearance to a natural tooth.
The BruxZir® Shaded block is available in different shapes such as Standard, D Blocks and Z Blocks. The sizes are: 12mm, 15mm, 20mm, 25mm, and 30mm. The drawings of different blocks are provided in this submission.
F. INDICATIONS FOR USE
The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
SUBSTANTIAL EQUIVALENCE G.
The following comparison chart outlines and provides the similarities and the substantial equivalency of the Prismatik™ Clinical Zirconia (Prismatik™ CZ)-K060104 and the BruxZir® Shaded. Prismatik believes that the comparative data presented in the preceding paragraphs, demonstrate that BruxZir® Shaded is essentially the same as currently marketed devices for the same indication for use, and supports our claim of substantial equivalence to predicate Class II devices under the classification of Porcelain powder for clinical use (21 CFR 872.6660) that have previously been found to be substantially equivalent, and that any differences between the BruxZir® Shaded and the predicate device do not introduce any new issues of safety or effectiveness. Both the modified device and the predicate device consist of general porcelain powder material (Product Code:
2
Image /page/2/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left and the company name on the right. The company name is written in a bold, sans-serif font.
EIH). Both the predicate device and the modified device have the same intended use.
| Elements of
Comparison | Prismatik™ Clinical Zirconia
(Prismatik™ CZ)-K060104
(predicate device) | Prismatik
BruxZir® Shaded (modified
device) |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| General Material | Powder, porcelain | Same |
| Raw Material
Supplier | Tosoh Corporation | Same |
| Indications | The device is indicated for use
by dental technicians in the
construction of custom made
all ceramic restorations for
anterior and posterior location | Same |
| Biocompatibility | Yes | Same |
| Sterility | Non-sterile | Same |
| Labeling of the
Intended Use | Same | Same
A minor change to the name from
Prismatik™ Clinical Zirconia
(Prismatik™ CZ to BruxZir® Shaded |
| Design | Various Sizes and Thicknesses
12mm, 15mm, 20mm, 25mm,
and 30mm | Same |
| Performance | Performance and technological
characteristics have been
previously cleared for market
(K060104) | Same |
Comparison of Predicate Devices
NON-CLINICAL TESTING H.
Applicable testing was performed in accordance with the Design Verification Plan including a Risk Analysis addressing the impact of changes to the device. The test results indicate the Prismatik BruxZir® Shaded Blank is comparable to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is a triangle with a smaller triangle cut out of it. The company name is written in a bold, sans-serif font.
I.
BIOCOMPATIBILITY
Non-clinical test data was used to support the substantial equivalency.
The functionality of the BruxZir® Shaded Blocks as well as their conformance to design input was further determined by laboratory testing. BruxZir® Shaded has been tested for Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), and Irritation (ISO 10993-10) tests to meet the biocompatibility requirement and the reports are as follow:
- · The Cytotoxicity Report shows that there was no reaction on any of the cells.
- · The Sensitization Report shows that there was no reaction on the tested subject.
- · The Irritation Report shows that there was no erythema or edema on the test subject.
| Test Description | Results |
|---|---|
| Cytotoxicity Study using the IX MEM extraction | |
| method at 37°C | Pass |
| ISO Intracutaneous Study, Extract 0.9% sodium | |
| chloride USP solution (SC) and sesame oil, NF (SO) | Pass |
| Irritation and Skin Sensitization Study, Extract 0.9% | |
| sodium chloride USP and sesame oil, NF (SO) | Pass |
The BruxZir® product is manufactured from TZ-Series of zirconia powders free of organic binder material which exhibits superior mechanical properties, and it is a great material for dental restorations for the following four (4) physical properties such as high flexural strength, high fracture toughness (KIC), great resistance to thermal shock and most innovative, is the color and translucency.
4
Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered horizontally in the image. The background of the image is white.
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2013
Mr. Armin Zehtabchi Senior Regulatory Affairs Specialist Prismatik Dentalcraft, Incorporated 2212 Dupont Drive, Suite IJK IRVINE CA 92612
Re: K130924
Trade/Device Name: BruxZir® Shaded Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: April 12, 2013 Received: April 16, 2013
Dear Mr. Zehtabchi:
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. 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.
5
Page 2 - Mr. Zehtabchi
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kwame Ulmer -
S FDA
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory. Infection Control and
Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left and the company name on the right. The triangle is partially obscured by a white shape, creating a prism effect. The text is in a bold, sans-serif font.
005-Indications for Use Statement
510 (K) Number (if known): K130924
BruxZir® Shaded Device Name:
Indications for Use: The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
Prescription Use: Yes No No (Part 21 CFR 801 Subpart D)
Over-the-Counter Use: Yes | No > (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susan Runner, DOSMA | |
|---|---|
| -- | --------------------- |
| Digitally signed by Mary S. Runner - | |
|---|---|
| S | |
| DN: c=US, o=U.S. Government, | |
| ou=HHS, ou=FDA, ou=People, | |
| cn=Mary S. Runner S, | |
| 0.9.2342.19200300.100.1.1=130008 | |
| -7950 | |
| Date: 2015.03.08 12:36:47-04'00 |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K130924 |
|---|---|
| ---------------- | --------- |