(189 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of dental stains and glazes, with no mention of AI or ML technology.
No.
The device is used for coloration and finishing of dental restorations, not for treating any disease or condition. Its function is aesthetic and structural, related to the restoration itself.
No
Explanation: The device is described as "Universal Paste Stains and Glaze" intended for "coloration and finishing of glass ceramic and zirconia-based restorations," not for diagnosing medical conditions.
No
The device description clearly states that the product is based on "Silicate Sintered Glass Ceramic" and includes "stain pastes, a glazing paste, and a liquid," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "coloration and finishing of glass ceramic and zirconia-based restorations" in dental applications. This is a direct application to a medical device (dental restoration) for aesthetic and functional purposes, not for diagnosing a condition or disease.
- Device Description: The description clearly states the pastes "serve solely for the color staining and glazing of the surfaces of restorations." This reinforces the aesthetic and finishing nature of the product.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples from the human body (blood, urine, tissue, etc.) or to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of a disease or condition.
- Classification: The device is classified as "Porcelain powder for clinical use (21 C.F.R. § 872.6660)," which falls under the category of dental devices, not IVDs.
- Performance Studies: The performance studies focus on biocompatibility and solubility, which are relevant to materials used in dental restorations, not diagnostic accuracy.
In summary, the device's function is to modify the appearance and surface properties of dental restorations, which is a therapeutic/restorative application, not a diagnostic one.
N/A
Intended Use / 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.
Product codes
EIH
Device Description
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.
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 applications
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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, |
| 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/QA, 510(K) Project Manager | |
| Secondary Contact Person: | Marilyn Pourazar, (949) 225-1269 |
| 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.
2
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
-
- Melting
-
- Milling/Sieving
- ကဲ Shading
-
- 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 +423 237 48 58, and the fax number is +423 237 48 39. The email address is info@esteticceram.com, 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
Comparison | Prismatik™ Universal Paste Stains
and Glaze | 3M's Bellus Shading Kit-
K090718 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| General Material | Powder, porcelain | Same |
| Indications | 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. | Color staining and glazing of
glass ceramic restorations
made from 3M ESPE's Glass
Ceramics "Jolly." |
| Biocompatibility | Yes | Same. |
| Sterility | Non-sterile | Same |
| Machining and
Sintering | Yes | Same |
| Performance | Simulating the natural tooth dentine | Same |
Comparison of the Technological Characteristics of the New Device and the Predicate Devices
4
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.
6
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/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 (800) 638-2041 or (301) 796-7100 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 :