Post Cement Hi-X Dental Cement is a self-cured, radiopaque composite and is designed to be used with Bisco's dental adhesive systems such as All-Bond 2 or One-Step Universal Adhesive Systems. Post Cement Hi-X will bond micro-mechanically to fiber posts, metal, silane-treated porcelain, fibers and tooth structure. Due to its high opacity in thin layers, Post Cement Hi-X is intended for cementation of posts. When viewed on x-ray film, the outline of any post material with the use of Post Cement Hi-X. Post Cement Hi-X, a low-viscosity, tooth-colored, silica and glass-filled, resin-based composite, is a two-paste, self-cured system. The material is supplied in syringes.

AI/ML Overview

The provided text describes a 510(k) summary for a dental cement called "Post Cement Hi-X". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics that would typically involve a "test set," "ground truth," or "expert adjudication" in the context of AI/medical device performance studies.

Therefore, many of the requested items (2-9) are not applicable or cannot be extracted from the given text because the regulatory submission is not for an AI/imaging device requiring such detailed performance study information. The submission is for a material (dental cement) where "acceptance criteria" are related to its physical and chemical properties and intended use.

Here's the information that can be extracted or inferred based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific submission, "acceptance criteria" are implicitly defined by the properties of the predicate device that the new device aims to be substantially equivalent to. The "reported device performance" are the characteristics of the new device.

Technological Characteristic	Acceptance Criteria (Predicate: C & B Luting Cement)	Reported Device Performance (Post Cement Hi-X)
Intended Use	Cementation of fixed restorations of precious, semi-precious and non-precious metals and of porcelain and composite fixed prostheses.	Cementation of posts and cementation of precious, semi-precious and non-precious metal posts.
Chemical Composition	Self-cured	Self-cured
Physical/Mechanical Properties	High strength, resistant to wear and abrasion	High strength, resistant to wear and abrasion
Working Time (room temp)	3-4 minutes	2.5-3.0 minutes
Setting Time (room temp)	5-7 minutes	4.5-5.0 minutes
Radiopacity	Not explicitly stated for predicate in table, but implied by new device's description of being "radiopaque composite" and "outline of any post material... on x-ray film."	Radiopaque (description states: "radiopaque composite", "high opacity in thin layers", "viewed on x-ray film").
Viscosity/Composition	Not explicitly stated for predicate.	Low-viscosity, tooth-colored, silica and glass-filled, resin-based composite.
System	Not explicitly stated for predicate.	Two-paste, self-cured system.
Delivery	Not explicitly stated for predicate.	Supplied in syringes.

Study to Prove Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (i.e., is substantially equivalent to the predicate) is not a formal clinical trial or a performance study with a test set in the conventional sense of an AI/imaging device. Instead, it is a comparison of technological characteristics as presented in the table above, demonstrating that the new device has the same technological characteristics as the predicate device or that any differences do not raise new questions of safety or effectiveness. The FDA's 510(k) clearance process itself serves as the "proof" that the regulatory body has accepted this comparison.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/imaging device requiring a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/imaging device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 is not an AI/imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/imaging device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI/imaging device's ground truth. For this dental cement, the "ground truth" for its properties would be established through standard material testing methods (e.g., ISO standards for dental materials) which are not detailed in this summary.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that uses a "training set."

9. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

Summary

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AUG 25 25 099

Attachment 5-510(k) Summary

1. Bisco, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 847-534-6000 Contact: Kathryn B. Patterson, Regulatory Affairs Manager Date Prepared: July 2, 1999

2. Device Trade Name:	Post Cement Hi-X
Common/Usual Name:	Dental Post Cement
Classification Name:	Dental Cement

1. Predicate Device: C & B Luting Cement, K940030 (cleared February 4, 1994)
1. Post Cement Hi-X Dental Cement is a self-cured, radiopaque composite and is designed to be used with Bisco's dental adhesive systems such as All-Bond® 2 or One-Step® Universal Adhesive Systems. Post Cement Hi-X will bond micro-mechanically to fiber posts, metal, silane-treated porcelain, fibers and tooth structure. Due to its high opacity in thin layers, Post Cement Hi-X is intended for cementation of posts. When viewed on x-ray film, the outline of any post material with the use of Post Cement Hi-X. Post Cement Hi-X, a low-viscosity, tooth-colored, silica and glass-filled, resin-based composite, is a two-paste, self-cured system. The material is supplied in syringes.
1. The intended use of Post Cement Hi-X is:
- for the cementation of posts
- . for the cementation of metal posts fabricated with precious, semi-precious or non-precious metals
1. Post Cement Hi-X possesses the same technological characteristics as the predicate device, C & B Luting Cement. Below is a table which shows a side-by-side comparison of the technological characteristics.

Technological Characteristic	C & B Luting Cement	Post Cement Hi-X
Intended Use	Cementation of fixedrestorations ofprecious, semi-preciousand non-preciousmetals and of porcelainand composite fixedprostheses.	Cementation of postsand cementation ofprecious, semi-precious and non-precious metal posts
Chemical Composition	Self-cured	Self-cured
Physical/Mechanical Properties	High strength, resistantto wear and abrasion	High strength,resistant to wear andabrasion

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Working Time (room temperature)	3-4 minutes	2.5-3.0 minutes
Setting Time (room temperature)	5-7 minutes	4.5-5.0 minutes

and the control control consideration of the consideration of the consistential

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 25 1999

Ms. Kathryn B. Patterson Requlatory Affairs Manager Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

K992248 Re : Post Cement Hi-X Trade Name: Regulatory Class: II Product Code: EBF Dated: July 2, 1999 Received: July 6, 1999

Dear Ms. Patterson:

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 Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Patterson

This letter will allow you to begin marketing your device as This lecter will allow your warket notification. The FDA described in your 510 m, promilence of your device to a legally marketed predicate device results in a classification for your marketed predicate device rusules and the to proceed to the market.

If you desire specific advice for your device on our labeling II you desire specific additionally 809.00 for in regulation (21 crk Farc 301 and sease contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compilance at (501) 333 issing of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the office of Companding by reference to the regulation encification" (21 CFR 807.97). Other general premation on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance obtained from the Drvibion on 638-2041 or (301) 443-6597 or at at its coll-free namber (000) os fea.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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Attachment 2 -- Indications for Use

Indications for Use

510(k) Number (if known):__ K 992248 ______________________________________________________________________________________________________________________________________________________________________________

Device Name: Post Cement Hi-X Dental Cement

Indications for Use:

Cementation of posts 1.
Cementation of posts fabricated with precious, semi-precious or non-precious metals 2.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	X OR
------------------------------------------	------

Susan Fraser

(Division Sign-Off)
Division of Dental, Infection Control,and General Hospital Devices
510(k) Number	K992241

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.