Glasionomer FX-II is a glass polyalkenoate cement used for dental restorations. Glasionomer FX-II is intended for use as a final restorative for deciduous teeth; a geriatric restorative for Class I, II, III and V cavities and cervical erosions; a final restorative for Class I and II of adult dentition in non-load bearing situations; an intermediate restorative for heavy stress cavities; a core build up; and for pit and fissure fillings.

Device Description

Glasionomer FX-II is a glass polyalkenoate cement used for dental restorations, for Minimal Intervention (MI) dentistry.

AI/ML Overview

This document describes a 510(k) premarket notification for the "GlasIonomer FX-II" dental cement. The key information regarding performance and testing is found in the "Biocompatibility" section.

Here's the breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance (Passed)
Acute oral toxicity	Acute oral toxicity
Bacterial reverse mutation	Bacterial reverse mutation
In vitro cytotoxicity	In vitro cytotoxicity
Subcutaneous implantation	Subcutaneous implantation
Sensitization	Sensitization

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for each biocompatibility test. It also does not provide information on the data provenance (e.g., country of origin, retrospective/prospective). Dental cements are typically tested in vitro and in vivo (animal models) for biocompatibility, but the details are not included here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. Biocompatibility testing itself generates objective results (e.g., cell viability, mutation rates) rather than relying on expert interpretation for "ground truth" in the way an imaging AI model might. The interpretation of these results against established standards would be done by qualified toxicologists or biologists, but their number and specific qualifications are not mentioned.

4. Adjudication method for the test set

This is not applicable as the biocompatibility tests produce objective results, not requiring an adjudication method like those used for human-reviewed data sets in AI studies.

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

An MRMC comparative effectiveness study is not mentioned because this document is describing a dental cement, not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable as the document describes a dental cement, not an algorithm.

7. The type of ground truth used

The "ground truth" for the biocompatibility tests is based on objective biological and toxicological measurements obtained through standard laboratory protocols. For example:

Acute oral toxicity: Measured physiological responses in test subjects after oral exposure.
Bacterial reverse mutation: Observation of bacterial colony growth on specific media.
In vitro cytotoxicity: Measurement of cell viability or death in culture.
Subcutaneous implantation: Histopathological examination of tissue reaction at the implant site.
Sensitization: Observation of allergic reactions in test subjects.

These are established scientific methods with defined endpoints, not expert consensus or pathology reports in the diagnostic sense.

8. The sample size for the training set

This is not applicable as the document describes a dental cement, not a machine learning model. Therefore, there is no "training set."

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for a dental cement.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letters 'K' and 'O', followed by the numbers '3', '1', '4', '6', and '7'. The characters are written in a bold, slightly irregular style, giving them a distinct, hand-drawn appearance.

510(k) Summary Shofu Dental Corporation Glasionomer FX-II

Submitted by:	Robert Noble, PresidentShofu Dental Corporation1225 Stone DriveSan Marcos, CA 92069-4059(760)736-3277FAX: (760)736-3276
Company Contact:	Robert Noble, President
Date Summary Prepared	May 2, 2003
Trade Name	Glasionomer FX-II
Common Name	Dental Cement
Classification	EMA
Product Code	872.3275(b)
Substantially Equivalent Devices	Fuji GP [510(k) Number - K961448]Hy Bond Glasionomer CX [510(k)Number - K940122]

Description of Glasionomer FX-II

Glasionomer FX-II is a glass polyalkenoate cement used for dental restorations, for Minimal Intervention (MI) dentistry.

Intended Use:

{1}------------------------------------------------

Components:

Glasionomer FX-II is available in two (2) different sets:

The 1-1 Set contains the following and is available in four (4) shades: A2, A3, A3.5 and B2:

Powder 15g ●
Liquid 8ml (10g) ●
Spatula ●
Cocoa Butter 1g ●
Mixing Pad .
Matrix Strips ●
Powder Scoop ●
Instructions for Use ●

The Mini Set contains the following and is available in the same four (4) shades: A2, A3, A3.5 and B2:

. Powder 6g
Liquid 2.8ml (3.5g) ●
Powder Scoop ●
Instructions for Use .

Refills are available: single powder (15g) for all four (4) shades and a single liquid (8ml).

Biocompatibility

Glasionomer FX-II passed the following biocompatibility tests:

Acute oral toxicity .
Bacterial reverse mutation ●
In vitro cytotoxicity .
Subcutaneous implantation ●
Sensitization ●

Conclusion

The Glasionomer FX-II is substantially equivalent to Fuji GP powder 510(k) K961448 and Hy-Bond Glasionomer CX liquid 510(k) K940122.

{2}------------------------------------------------

Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of the human form, with three wave-like lines emanating from it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 17 2003

Mr. Robert Noble President Shofu Dental Corporation 1225 Stone Drive San Marcos, California 92069-4059

Re: K031467

Trade/Device Name: GlasIonomer FX-II Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA Dated: May 02, 2003 Received: May 20, 2003

Dear Mr. Noble:

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.

{3}------------------------------------------------

Page 2 - Mr. Robert Noble

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 (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.

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 your 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 Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Runner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation ' Center for Devices and Radiological Health

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: Glasionomer FX-II

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Keun Muly for KSN

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K031467

(Optional Format (3-10-98)

Shofu Dental Corporation Glasionomer FX-II 510(k) Premarket Notification

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.