PhoGlass Cem is intended to be used as an insoluble cement for cementing of crowns and bridges, inlays and onlays (metal and ceramic fused to metal), stainless steel crowns, orthodontic bands and used as a base or a liner.

Device Description

PhoGlass Cem is a dental glass ionomer cement intended to be used as an cement for cementing of crowns and bridges, inlays and onlays (metal and ceramic fused to metal), stainless steel crowns, orthodontic bands and used as a base or a liner.

AI/ML Overview

The provided document is a 510(k) premarket notification for a dental cement called PhoGlass Cem. This type of notification focuses on demonstrating substantial equivalence to a predicate device rather than on presenting extensive clinical study data and performance metrics typically associated with AI/ML-based medical devices or diagnostic tools.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set information.

Instead, the document primarily establishes:

Device Name: PhoGlass Cem
Intended Use: Cementing crowns and bridges, inlays and onlays (metal and ceramic fused to metal), stainless steel crowns, orthodontic bands, and as a base or liner.
Predicate Device: Fuji I (GC Corporation)
Substantial Equivalence Claim: PhoGlass Cem functions similarly and has the same intended use as the predicate device.

Without the specific clinical or performance study data, I cannot populate the requested table and answer the detailed questions.

Here is an explanation of why the requested information is absent from this specific type of document:

510(k) Premarket Notification: This regulatory pathway is used for medical devices that are substantially equivalent to a legally marketed predicate device. The primary focus is on demonstrating this equivalence in terms of intended use, technological characteristics, and safety and effectiveness, often through bench testing and comparison to the predicate, rather than through new, large-scale clinical trials that would generate the detailed performance metrics requested.
Type of Device: A dental cement is a material, and its performance is typically evaluated through physical and chemical properties (e.g., compressive strength, film thickness, solubility) rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are common for AI/ML devices.
Content of the Document: The provided text is the "Summary of Safety and Effectiveness" and the FDA's clearance letter. Neither of these sections would typically include the detailed study methodology or comprehensive performance results that you've asked for, especially for a device of this nature undergoing a 510(k) clearance.

Summary

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13. Summary of Safety and Effectiveness

K083766

Submitter

Name of company: S&C Polymer Silicon- und Composite Spezialitaeten GmbH Address: Robert-Bosch-Strasse 5, D-25335 Elmshorn (Germany) Phone: 0049 4121 483 0 Fax: 0049 4121 483 184 Contact Person: Dr. Christian Boettcher

Date of preparation: December 2008

Device Name:

Trade name: PhoGlass Cem Common Name: PhoGlass Cem Classification Name: Cement Dental, per 21CFR § 872.3275

Devices for which Substantial Equivalence is Claimed:

Fuji I (GC Corporation)

Device description:

Intended Use of the Device:

The device is designed for cementing-applications for dental purposes.

Substantial Equivalence:

PhoGlass is substantially equivalent to other legally marketed devices in the United States. The products marketed by S&C Polymer Silicon- und Compositen Spezialitaeten GmbH function in a manner similar to and is intended for the same use as the product marketed by GC.

MAR - 2 2009

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Christian Boettcher Regulatory Compliance Officer S&C Polymer GmbH Robert-Bosch-Strasse 5 D-25335 Elmshorn GERMANY

MAR - 2 2009

Re: K083766

Trade/Device Name: PhoGlass Cem Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA and EJK Dated: December 17, 2008 Received: December 22, 2008

Dear Dr. Boettcher:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Grytte H. Michie Oms.

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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11. Statement of Indication for Use

510(k) Number (if known):

Device Name:

PhoGlass Cem

Indications for Use:

PhoGlass Cem:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sipe Runser

Offsion Sign-Off) Onnson of Anesthesiology, General Hospital mecuon Control, Dental Devices

Number: K0837/06

Prescription Use:

Over-The-Counter Use

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.