BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 by BISCO, INC.

Luting metal crowns, bridges, inlay, and onlays including porcelain-fused-to-metal and composite-to-metal varieties;
Luting resin crowns, bridges, inlays, onlays and veneers;
Luting metal or non-metal/fiber posts;
Luting orthodontic appliances;
Luting porcelain inlays, onlays, crowns, and veneers (includes alumina and zirconia).

Device Description

BisCem is a dual-cured self etching and self adhosive resin cement. It is a self-adhesive cement since it bonds to composite, metal, silanated porcelain and tooth structure without applying any adhesive. No etching step is required to bond to dentin or enamel. With its dual syringe system. BisCem can be self cured by simply mixing paste B or cured by light after mixing paste A and paste B. Using a mixing tip, the cement could be dispensed to the working area directly. It is intended for use as a luting cement. Due to the unique chemistry of BisCem, refrigeration is necessary when not in use. Allow refrigerated BisCem to reach room temperature before use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental cement called BisCem. The purpose of this submission is to demonstrate that a modified version of BisCem is substantially equivalent to a legally marketed predicate device (the original BisCem, K060701).

Here's an analysis based on your request, structured to address each point:

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

The provided summary does not explicitly state specific numerical acceptance criteria for performance parameters such as bond strength, film thickness, or radiopacity. Instead, it relies on a qualitative statement of "significant performance characteristics" and "side by side comparisons."

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Intended Use	Luting cement
Chemical Composition	Dual-cured (self/light) dental glass filled, resin cement
Mechanical/Physical Properties	Low viscosity, dispensable composite
Safety and Efficacy	"proven the safety and efficacy of this product"

Note: The submission highlights that the modified formula is a "dual-cured radiopague dental cement" and that "Its physical properties are similar to the predicate device." This implies that the properties (e.g., bond strength, film thickness, radiopacity, handling characteristics) were compared to the predicate, and met the unstated acceptance criteria of being "similar" or "substantially equivalent." However, no specific numerical values or ranges are provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide any details regarding:

The sample size used for any testing.
The data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

This information is not applicable to this type of device submission. This is a dental material, and the "ground truth" for its performance would typically come from laboratory tests (e.g., bond strength testing, film thickness measurements, solubility, radiopacity assessment) and potentially in-vitro or in-vivo animal studies, not from human expert consensus on a test set in the way an AI diagnostic device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the reasons stated in point 3.

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

This information is not applicable. This is a dental material, not an AI diagnostic device that assists human readers.

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

This information is not applicable. This is a dental material, not an algorithm, so "standalone performance" in this context refers to the material's properties as measured in laboratory or clinical studies, without human intervention in the measurement process itself (beyond performing the test according to protocol). The summary does not provide details on these specific tests or their methodology.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this type of device (dental cement), the "ground truth" would be established through objective physical and chemical property measurements performed in a laboratory, and potentially through clinical observations (though no clinical studies are mentioned in this summary). Examples of such measurements include:

Bond strength (e.g., to dentin, enamel, metals, ceramics)
Film thickness
Radiopacity
Solubility
Setting time
Flexural strength
Compressive strength

The summary implies that these types of tests were conducted to demonstrate "physical properties are similar to the predicate device" and that "side by side comparisons clearly demonstrate that the applicant device is substantially equivalent."

8. The sample size for the training set

This information is not applicable. This is a dental material, not an AI model requiring a training set.

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

This information is not applicable for the reasons stated in point 8.

Summary of the Study:

The study referenced is a 510(k) premarket notification (K082449) submitted by Bisco, Inc. for a modified dental luting cement named BisCem. The core of such a submission is to demonstrate substantial equivalence to a previously cleared predicate device (in this case, the original BisCem, K060701, cleared in 2006).

The "study" or testing performed involved a side-by-side comparison of the modified BisCem with the predicate device. The goal was to show that:

The modified device has the same intended use.
Its chemical composition, while slightly changed (from "resin modified glass ionomer" to "resin cement"), results in "dual-cured (self/light) dental glass filled, resin cement" which is considered functionally equivalent to the predicate.
Its mechanical/physical properties are similar (low viscosity, dispensable composite).
Overall, the safety and efficacy of the modified product were proven through this comparison, leading to the conclusion of substantial equivalence.

The specific test methods, number of samples, or detailed results are not present in this Special 510(k) Summary. The FDA's clearance letter confirms their review of the submission and their determination of substantial equivalence, allowing the device to be marketed.

Summary

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K052449

Section 8 SPECIAL 510 (k) SUMMARY

SEP 2 5 2008

Applicant:	Bisco, Inc.1100 W. Irving Park RoadSchaumburg IL, 60193
Contact Person:	Michelle Schiltz-TaingTel: 847-534-6000Fax: 847-534-6111
Date Prepared:	August 22, 2008
Trade Name:	BisCem
Common Name:	Luting Cement
Classification/Name:	Material, Dental CementClass II per 21 CFR 872.3275

Description of Applicant Device:

Intended uses of Applicant Device:

The modified formula is a dual-cure radiopague dental cement designed to be used as a luting cement. Its physical properties are similar to the predicate device and there has been no change in the intended use.

Predicate Devices: BisCem cleared under (K060701) dated May 15, 2006.

	BisCem	Modified
Intended use	Luting cement	Luting cement
Chemical composite	Dual-cured (self/light) dental glassfilled, resin modified glass ionomercement	Dual-cured (self/light) dentalglass filled, resin cement
Mechanical /physicalproperties	Low viscosity, dispensablecomposite	Low viscosity, dispensablecomposite

Significant Performance Characteristics:

Side by side comparisons clearly demonstrate that the applicant device is substantially equivalem to the legally marketed device. It is concluded that the information supplied in this submission has proven the safety and efficacy of this product.

Page 8-1

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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 stylized eagle with three bars representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

SEP 2 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Michelle Schiltz-Taing Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

Re: K082449

Trade/Device Name: BISCEM Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: August 22, 2008 Received: September 5, 2008

Dear Ms. Schiltz-Taing:

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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Page 2 - Ms. Schiltz-Taing

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I DA has made a determination that your device complics 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 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" (21CFR 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,

TKhamult-Kendring
foel

Chiu S. Lin. Ph. D Division 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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510 (k) Number (if known): K

BISCEM Device Name:

Indications for Use:

1. Luting metal crowns, bridges, inlay, and onlays including porcelain-fused-tometal and composite-to-metal varieties;
  K082449
1. Luting resin crowns, bridges, inlays, onlays and veneers;
1. I Luting metal or non-metal/fiber posts;
1. Luting orthodontic appliances;
1. Luting porcelain inlays, onlays, crowns, and veneers (includes alumina and zirconia).

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

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

510(k) Number: K082449

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.