UNIVERSAL PASTE STAINS AND GLAZE

K130604 · Prismatik Dentalcraft, Inc. · EIH · Sep 12, 2013 · Dental

Device Facts

• Record ID: K130604
• Device Name: UNIVERSAL PASTE STAINS AND GLAZE
• Applicant: Prismatik Dentalcraft, Inc.
• Product Code: EIH · Dental
• Decision Date: Sep 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Prismatik's Universal Paste Stains and Glaze are intended to be used in dental applications for coloration and finishing of glass ceramic and zirconia-based restorations.

Device Story

Universal Paste Stains and Glaze are silicate sintered glass ceramic materials used for dental restoration finishing. The system includes 17 stain shades, a fluorescent paste glaze, and a thinning liquid. The device is used by dental professionals to apply color and esthetic finishing coats to glass ceramic and zirconia-based restorations. The fluorescent glaze provides esthetic properties under UV light. The liquid is used to adjust paste consistency and clean brushes. The device is applied to the surface of restorations, which are then sintered to achieve the final finish, simulating natural tooth dentine.

Clinical Evidence

Bench testing only. Biocompatibility testing performed including cytotoxicity (DIN EN ISO 10993-5) with negative results. Chemical solubility testing performed according to DIN EN ISO 6872, showing composition and solubility similar to predicate.

Technological Characteristics

Silicate sintered glass ceramic porcelain powder. Includes stain pastes, fluorescent paste glaze, and thinning liquid. Non-sterile. Biocompatible per ISO 10993-5. Solubility per DIN EN ISO 6872. Requires machining and sintering.

Indications for Use

Indicated for coloration and finishing of glass ceramic and zirconia-based dental restorations.

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

• 3M's Bellus Shading Kit (K090718)

Submission Summary (Full Text)

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K130604

# 005-510 (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.

### A. SUBMITTER INFORMATION

| 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/QA, 510(K) Project Manager |
| Secondary Contact Person: | Marilyn Pourazar, [phone]<br>Senior Director, RA/QA |
| Date Summary Prepared: | June 21, 2013 |

### DEVICE IDENTIFICATION B.

·

| Trade/Proprietary Name: | Universal Paste Stains and Glaze |
|-------------------------|-----------------------------------|
| 21 CFR Reference: | 21 CFR 872.6660 |
| 21 CFR Common Name: | Porcelain powder for clinical use |
| Classification: | Class II |
| Product Code: | EIH |
| Panel: | Dental |

### IDENTIFICATION OF PREDICATE DEVICE C.

Trade/Proprietary Name: 3M's Bellus Shading Kit-K090718

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#### DEVICE DESCRIPTION D.

Prismatik's Universal Paste Stains and Glaze are based on Silicate Sintered Glass Ceramic that is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660) and are available in a variety of colors. They include stain pastes, a glazing paste, and a liquid which can be used to thin the pastes. The pastes serve solely for the color staining and glazing of the surfaces of restorations.

The Universal Paste Stains and Glaze contains 17 stain shades, Fluorescent Paste Glaze, and Stain and Glaze Liquid, which are all silicate glass based.

The Stains are available in colors A, B, C, D and A Light, C Light, C Light, D Light, as well as White, Yellow, Orange, Brown, Dark Brown, Blue, Purple, Dark Pink, and Grey. The Fluorescent Paste Glaze is used to achieve an esthetic finishing coat. It also provides fluorescent properties under ultra-violet lighting. The Stain and Glaze Liquid can be mixed with the pastes in order to modify the consistency, and can also be used to clean the brush.

Image /page/1/Picture/4 description: The image shows a collection of small, round containers arranged in a rectangular tray. Each container has a label indicating a different color or shade, such as "Shade A," "Shade B," "yellow," "orange," "purple," and "grey." The containers appear to hold stain paste, as indicated by the text on the labels. There is also a bottle and a small tool in the tray.

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# Work flow past production:

The work flow paste production includes melting, milling/sieving, shading and paste preparation, and the process flow is demonstrated below:

Image /page/2/Picture/2 description: The image shows a logo with the words "estetic ceram" written in a simple, sans-serif font. Above the text is a circular design made up of various sized dots, creating a visual element that resembles a stylized flower or burst. The overall design is clean and modern, suggesting a brand identity for a company related to aesthetics or ceramics.

Work flow paste production, glaze/stains/shades ZT

- 1. Melting
- 2. Milling/Sieving
- ကဲ Shading
- 4. Paste preparation

Image /page/2/Figure/8 description: The image shows a flowchart of a process. The process starts with four different steps: Melting, Milling/Sieving, Shading, and Paste Preparation. Each of these steps leads to further sub-steps, such as "Melting in continuous melting furnace" and "Jet milling", eventually leading to the final step, "Finished Product".

Image /page/2/Figure/9 description: The image shows the logo and contact information for estetic ceram ag. The address is Austrasse 15, Postfach 223, 9495 Triesen, Liechtenstein. The phone number is [phone], and the fax number is [phone]. The email address is [e-mail], and the website is www.esteticceram.com.

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### INDICATIONS FOR USE E.

Prismatik's Universal Paste Stains and Glaze are intended to be used in dental applications for coloration and finishing of glass ceramic and zirconia-based restorations.

### SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE NEW F. DEVICE AND THE PREDICATE DEVICES

The following comparison table of the technological characteristics of the new device and the predicate devices outlines and provides the similarities and the substantial equivalency of the Prismatik's" Universal Paste Stains and Glaze and the 3M's Bellus Shading Kit-K090718.

| Elements of<br>Comparison | Prismatik™ Universal Paste Stains<br>and Glaze | 3M's Bellus Shading Kit-<br>K090718 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| General Material | Powder, porcelain | Same |
| Indications | Prismatik's Universal Paste Stains<br>and Glaze are intended to be used in<br>dental applications for coloration and<br>finishing of glass ceramic and<br>zirconia-based restorations. | Color staining and glazing of<br>glass ceramic restorations<br>made from 3M ESPE's Glass<br>Ceramics "Jolly." |
| Biocompatibility | Yes | Same. |
| Sterility | Non-sterile | Same |
| Machining and<br>Sintering | Yes | Same |
| Performance | Simulating the natural tooth dentine | Same |

## Comparison of the Technological Characteristics of the New Device and the Predicate Devices

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#### DETERMINITION OF SUBSTANTIAL EQUIVALENCE G.

The above comparison table of the technological characteristics of the new device and the predicate devices was provided for the substantial equivalency of the Prismatik's Universal Paste Stains and Glaze and the 3M's Bellus Shading Kit-K090718. Prismatik believes that the comparative data presented, demonstrate that Prismatik ""Universal Paste Stains and Glaze are 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. Both the new and the predicate device consist of general porcelain powder material (Product Code: EIH), that is biocompatible for the same indication for use.

#### SUMMARYOF NON-CLINICAL TESTING H.

Non-clinical test data was used to support the substantial equivalency. To provide evidence for safety, a biocompatibility testing was carried out. The raw materials were tested for cytotoxicity (acc. DEN EN ISO 10993-5) with negative result. From chemical point of view, the porcelains investigated were similar in composition and show similar solubility acc DIN EN ISO 6872.

#### CONCLUSION FROM THE NON-CLINICAL TESTING I.

The results of the above described studies demonstrate that Prismatik's Universal Paste Stains and Glaze is as safe and effective as the cleared predicate device.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

### September 12, 2013

Prismatik Dentalcraft, Inc. C/O Mr. Armin Zehtabchi Senior RA Specialist 2212 Dupont Drive, Suite IJK Irvine, CA 92612

Re: K130604

Trade/Device Name: Universal Paste Stains and Glaze Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH Dated: June 26, 2013 Received: June 27, 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/ResourcesforYou/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,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division 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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Image /page/7/Picture/0 description: The image shows a logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left and the company name on the right. The triangle is filled with a pattern of black and white shapes. The text is in a simple, sans-serif font.

004-Indications for Use Statement

510 (K) Number (if known): K I 30604

Universal Paste Stains and Glaze Device Name:

Indications for Use: Prismatik's Universal Paste Stains and Glaze are intended to be used in dental applications for coloration and finishing of glass ceramic and zirconia-based restorations.

Prescription Use: Yes > No _ (Part 21 CFR 801 Subpart D)

Over-the-Counter Use: Yes [ No Z (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BEL.OW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

# Andrew I. Steen -S 2013.09.12 11:34:27 -04'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices 510 (k) Number :