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 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.

AI/ML Overview

The provided document is a 510(k) summary for the "Universal Paste Stains and Glaze" device. This is a premarket notification for a medical device that aims to demonstrate substantial equivalence to an already legally marketed device (predicate device). Such submissions typically do not involve the kind of elaborate clinical studies with acceptance criteria, sample sizes, ground truth establishment, and expert involvement that would be typical for a novel high-risk device or an AI/software as a medical device (SaMD).

Instead, this submission relies on demonstrating technological characteristics equivalency and non-clinical testing (biocompatibility and chemical similarity) to assert that the new device is as safe and effective as the predicate device.

Therefore, many of the requested categories are not applicable or not explicitly detailed in this type of regulatory submission.

Here's an analysis based on the provided text:

Acceptance Criteria and Study to Prove Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criterion	Reported Device Performance	Notes
Biocompatibility	Negative result for cytotoxicity (per DEN EN ISO 10993-5)	Raw materials tested for cytotoxicity with negative result.	This demonstrates that the device's components are not toxic to cells, meeting a fundamental safety requirement. The acceptance criterion is a "negative result," meaning no cytotoxic effect was observed.
Solubility	Similar to predicate device (per DIN EN ISO 6872)	Porcelains investigated were similar in composition and show similar solubility acc DIN EN ISO 6872.	This indicates that the device's material properties, specifically its behavior in a physiological environment, are comparable to the already approved predicate device, ensuring similar safety and performance in terms of material degradation or leaching. The acceptance criterion is "similar solubility" to the predicate.
Technological Characteristics (General Material, Indications, Sterility, Machining/Sintering, Performance)	Substantially equivalent to predicate device	Demonstrated in comparison table: "Same" or equivalent statements for most characteristics like "Powder, porcelain" for General Material, "Non-sterile" for Sterility, "Yes" for Machining and Sintering, and "Simulating the natural tooth dentine" for Performance. Indications for Use are similar in scope, though phrasing differs: "coloration and finishing of glass ceramic and zirconia-based restorations" (new device) vs. "Color staining and glazing of glass ceramic restorations made from 3M ESPE's Glass Ceramics 'Jolly'" (predicate).	This is the core of a 510(k) submission. The acceptance criterion is "substantial equivalence" in these aspects. The reported performance is that these characteristics are functionally identical or very similar to the predicate device, supporting the claim of equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of clinical performance data. The non-clinical tests (biocompatibility, solubility) would have involved specific test samples (e.g., raw materials, porcelain batches), but specific numbers are not given.
Data Provenance: The studies were non-clinical, laboratory-based tests ("biocompatibility testing was carried out," "raw materials were tested," "porcelains investigated"). Not applicable to country of origin or retrospective/prospective in a clinical sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This submission focuses on non-clinical, laboratory-based testing (biocompatibility, chemical properties) and comparison of technological characteristics, not on clinical performance evaluated by experts making diagnoses or assessments. Ground truth in this context would be objective laboratory measurements against established standards (e.g., ISO for cytotoxicity, DIN EN ISO for solubility).

4. Adjudication Method for the Test Set

Not applicable. There were no human expert adjudications for the non-clinical tests. The tests would likely follow standardized protocols, and results would be interpreted by laboratory personnel based on the criteria defined in those standards (e.g., cell viability percentages for cytotoxicity).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a dental material (paste stains and glaze), not an AI/SaMD or an imaging device requiring human reader interpretation, nor does it involve human-plus-AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a physical material, not an algorithm or software.

7. The Type of Ground Truth Used

Objective Laboratory Standards and Measurements: For biocompatibility, the ground truth was defined by the criteria of the DEN EN ISO 10993-5 standard for cytotoxicity. For solubility, it was the measurements taken according to DIN EN ISO 6872, compared against the predicate device. For technological characteristics, the ground truth was the objective composition and physical properties of the materials themselves, alongside their intended use and manufacturing processes.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set.

Summary

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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,Irvine, CA 92612
Company Phone:	949-225-1269
Company FAX:	949-553-0924
Facility Registration Number:	3005477956
Primary Contact Person:	Armin Zehtabchi, (949) 225-1234Senior RA/QA, 510(K) Project Manager
Secondary Contact Person:	Marilyn Pourazar, (949) 225-1269Senior 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.

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

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
1. Milling/Sieving
ကဲ Shading
1. 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 ofComparison	Prismatik™ Universal Paste Stainsand Glaze	3M's Bellus Shading Kit-K090718
General Material	Powder, porcelain	Same
Indications	Prismatik's Universal Paste Stainsand Glaze are intended to be used indental applications for coloration andfinishing of glass ceramic andzirconia-based restorations.	Color staining and glazing ofglass ceramic restorationsmade from 3M ESPE's GlassCeramics "Jolly."
Biocompatibility	Yes	Same.
Sterility	Non-sterile	Same
Machining andSintering	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 (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 :

Regulation Number and Section

§ 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.