Adhesive cementation of all metal crowns and bridges including precious, semi-precious and non-precious metals
Adhesive cementation of conventional porcelain fused to metal crowns and bridges with metal margins
Adhesive cementation of gold inlays and onlays
Adhesive cementation of prefabricated and cast posts.
Adhesive cementation of porcelain/ceramic/composite substrate crowns
Adhesive cementation of porcelain jacket crowns (including foil or electroplated lined crowns)
Adhesive cementation of porcelain fused to metal (PFM) crowns with porcelain margins
Adhesive liner for bonding freshly placed direct amalgam restorations

Device Description

ADHESIVE HYBRID IONOMER CEMENT is a two-component, dualcure, high-strength hybrid ionomer dental cement used for permanent cementation of crowns and bridges, and for adhesive bonding of fresh direct amalgam to tooth structure. The cured product demonstrates adhesion to dentin and enamel, releases fluoride, and has suitable physical properties required for a dental luting cement, as well as a protective barrier.

AI/ML Overview

The provided text is a 510(k) summary for a dental cement, "ADHESIVE HYBRID IONOMER CEMENT." This document focuses on demonstrating substantial equivalence to a predicate device based on material properties and biocompatibility, rather than assessing the performance of a diagnostic device requiring clinical studies with acceptance criteria, sample sizes, and ground truth established by experts.

Therefore, many of the requested categories in your prompt are not applicable to the information contained in this 510(k) summary. I will address the applicable points and note where information is not available due to the nature of this submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical "acceptance criteria" in the way one might for diagnostic accuracy or clinical efficacy. Instead, it relies on demonstrating comparable physical properties and biocompatibility to a predicate device.

Acceptance Criteria Category	Reported Device Performance
Material Properties	"The physical properties of ADHESIVE HYBRID IONOMER CEMENT are comparable to Advance® Hybrid Ionomer Cement (K940914)."
Biocompatibility	- MEM Elution Test: Found to be non-cytotoxic.- Ames Mutagenicity Test: Found to be non-mutagenic.- Histopathologic Study (sub-human primates): "All responses were found to be acceptable."
Component Safety	"All of the components found in ADHESIVE HYBRID IONOMER CEMENT have either been used in legally marketed devices or have been found safe for dental use."

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

MEM Elution Test & Ames Mutagenicity Test: The specific sample sizes for these in-vitro tests are not mentioned in the summary.
Histopathologic Study: The number of sub-human primates used is not specified.
Data Provenance: The location or retrospective/prospective nature of the biocompatibility studies is not detailed.

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

Not applicable. The "ground truth" here relates to safety and material properties, assessed through standardized laboratory tests and a histopathologic study, not through expert consensus on diagnostic interpretations. For the histopathologic study, it's implied that qualified personnel (e.g., pathologists/veterinary pathologists) would interpret the results, but their number and specific qualifications are not stated.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for expert review of images or clinical cases to establish a ground truth. Here, the assessment is based on laboratory test results and histopathological findings.

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 cement, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.

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

Not applicable. This device is a dental cement; there is no algorithm or AI component involved.

7. The Type of Ground Truth Used

Laboratory Test Results: For non-cytotoxicity (MEM Elution) and non-mutagenicity (Ames Test).
Histopathological Findings: For the in-vivo study, the "ground truth" would be the observed tissue reactions assessed by trained experts (likely pathologists).
Component Safety: Established by prior use in legally marketed devices or general recognition of safety for dental use.

8. The Sample Size for the Training Set

Not applicable. As a material, there is no "training set" in the context of machine learning or AI. The development of the cement would involve formulation and testing, but not a dataset used for algorithm training.

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

Not applicable, as there is no training set for this type of device.

Summary

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510(k) SUMMARY

Image /page/0/Picture/1 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and connected to each other. The word is in black and the background is white.

K974140

NAME & ADDRESS:

JAN - 5 1998

DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax (717) 854-2343 P. J. Lehn Telefax (717) 849-4343

P. Jeffery Lehn CONTACT:

October 31, 1997 DATE PREPARED:

ADHESIVE HYBRID IONOMER CEMENT TRADE OR PROPRIETARY NAME:

872.3275 CLASSIFICATION NAME: Dental Cement

K940914 Advance® Hybrid Ionomer Cement PREDICATE DEVICE:

DEVICE DESCRIPTION: ADHESIVE HYBRID IONOMER CEMENT is a two-component, dualcure, high-strength hybrid ionomer dental cement used for permanent cementation of crowns and bridges, and for adhesive bonding of fresh direct amalgam to tooth structure.

The cured product demonstrates adhesion to dentin and enamel, releases fluoride, and has suitable physical properties required for a dental luting cement, as well as a protective barrier.

The physical properties of ADHESIVE HYBRID IONOMER CEMENT are comparable to Advance® Hybrid Ionomer Cement (K940914).

INTENDED USE: ADHESIVE HYBRID IONOMER CEMENT is used for adhesive cementation of: all metal crowns and bridges including precious, semi-precious and non-precious metals, conventional porcelain fused to metal crowns and bridges with metal margins, gold inlays and onlays, prefabricated and cast posts, porcelain/ceramic/composite substrate crowns, porcelain jacket crowns (including foil or electroplated lined crowns), porcelain fused to metal crowns with porcelain margins; and as an adhesive liner for bonding freshly placed direct amalgam restorations.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in ADHESIVE HYBRID IONOMER CEMENT have either been used in legally marketed devices or have been found safe for dental use.

ADHESIVE HYBRID IONOMER CEMENT (cured material) was tested by the MEM Elution Test and the Ames Mutagenicity Test, and found to be non-cytotoxic and non-mutagenic. A histopathologic study of the effects of the product cured in the teeth of sub-human primates was conducted. All responses were found to be acceptable.

We believe that the prior use of the components of ADHESIVE HYBRID IONOMER CEMENT in legally marketed devices, the performance data, and the results of biocompatibility testing support the safety and effectiveness of ADHESIVE HYBRID IONOMER CEMENT for the intended uses.

000044

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Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized lines forming the body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 5 1998

Mr. Jeffery P. Lehn Director of Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue York, Pennsylvania 17405

Re : K974140 Adhesive Hybrid Ionomer Cement Trade Name: Requlatory Class: II Product Code: EMA Dated: October 31, 1997 Received: November 3, 1997

Dear Mr. Lehn:

We have reviewed-your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Lehn

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 801.109)

K974/40

510(K) Number: Device Name:

ADHESIVE HYBRID IONOMER CEMENT

ADHESIVE HYBRID IONOMER CEMENT is used for:

· Adhesive cementation of all metal crowns and bridges including precious, semi-precious and non-precious metals
· Adhesive cementation of conventional porcelain fused to metal crowns and bridges with metal margins
· Adhesive cementation of gold inlays and onlays
· Adhesive cementation of prefabricated and cast posts.
· Adhesive cementation of porcelain/ceramic/composite substrate crowns
· Adhesive cementation of porcelain jacket crowns (including foil or electroplated lined crowns)
· Adhesive cementation of porcelain fused to metal (PFM) crowns with porcelain margins
· Adhesive liner for bonding freshly placed direct amalgam restorations

Concurrence of CDRH. Office of Device Evaluation (ODE)
(Division Sign-Off)	P.D. Scast for Susan Runner
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number	K974140

Prescription Use V

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.