BRUXZIR SHADED

K130924 · Prismatik Dentalcraft, Inc. · EIH · May 16, 2013 · Dental

Device Facts

• Record ID: K130924
• Device Name: BRUXZIR SHADED
• Applicant: Prismatik Dentalcraft, Inc.
• Product Code: EIH · Dental
• Decision Date: May 16, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

Device Story

BruxZir® Shaded Blanks are zirconia-based milling blocks used by dental technicians to fabricate full-contour crowns and bridges. Unlike traditional zirconia blanks that use organic binders and high-pressure mechanical pressing, these blanks are manufactured via a colloidal process using vacuum slip casting with Plaster of Paris molds. This process utilizes smaller zirconia particles dispersed with TMAOH, resulting in improved microstructure, homogeneity, and translucency. The blanks are available in four thicknesses (12, 15, 20, 25 mm) and four shades. The final restorations provide high flexural strength, fracture toughness, and thermal shock resistance, mimicking the appearance of natural teeth. The device is a material supply for dental laboratories; it does not involve software or automated analysis.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Irritation). All tests passed with no adverse reactions (erythema, edema, or cell reaction) reported.

Technological Characteristics

Material: Zirconia powder (TZ-Series). Manufacturing: Colloidal process via vacuum slip casting; no organic binders. Dimensions: 12mm, 15mm, 20mm, 25mm, 30mm. Properties: High flexural strength, fracture toughness (KIC), thermal shock resistance. Biocompatibility: ISO 10993-5, ISO 10993-10. Non-sterile.

Indications for Use

Indicated for dental technicians constructing custom all-ceramic restorations for anterior and posterior locations.

Regulatory Classification

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.

Predicate Devices

• Prismatik™ Clinical Zirconia (Prismatik™ CZ)-K060104

Submission Summary (Full Text)

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B.

C.

Trade/Proprietary Name:

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K130924

# 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,<br>Irvine, CA 92612 |
| Company Phone: | 949-225-1269 |
| Company FAX: | 949-553-0924 |
| Facility Registration Number: | 3005477956 |
| Primary Contact Person: | Armin Zehtabchi, [phone]<br>Senior RA Specialist |
| Secondary Contact Person | Marilyn Pourazar, [phone]<br>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

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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:

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EIH). Both the predicate device and the modified device have the same intended use.

| Elements of<br>Comparison | Prismatik™ Clinical Zirconia<br>(Prismatik™ CZ)-K060104<br>(predicate device) | Prismatik<br>BruxZir® Shaded (modified<br>device) |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| General Material | Powder, porcelain | Same |
| Raw Material<br>Supplier | Tosoh Corporation | Same |
| Indications | The device is indicated for use<br>by dental technicians in the<br>construction of custom made<br>all ceramic restorations for<br>anterior and posterior location | Same |
| Biocompatibility | Yes | Same |
| Sterility | Non-sterile | Same |
| Labeling of the<br>Intended Use | Same | Same<br>A minor change to the name from<br>Prismatik™ Clinical Zirconia<br>(Prismatik™ CZ to BruxZir® Shaded |
| Design | Various Sizes and Thicknesses<br>12mm, 15mm, 20mm, 25mm,<br>and 30mm | Same |
| Performance | Performance and technological<br>characteristics have been<br>previously cleared for market<br>(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.

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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<br>method at 37°C | Pass |
| ISO Intracutaneous Study, Extract 0.9% sodium<br>chloride USP solution (SC) and sesame oil, NF (SO) | Pass |
| Irritation and Skin Sensitization Study, Extract 0.9%<br>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.

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## 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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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 |
|----------------|---------|
|----------------|---------|