1. Metal crowns, bridges, inlays and onlays (includes porcelain-fused-to-metal and composite-to-metal)
1. Porcelain, Ceramic Crowns, inlays and onlays (includes alumina and zirconia)
1. Resin crowns, bridges, inlays and onlays (resin-based composite-ceramic hybrid)
1. Metal (prefabricated or cast) and non-metal/fiber endodontic posts
1. Implant supported restorations
1. Orthodontic Appliances (brackets, bands)

Device Description

TheraCem is a self-etching, self-adhesive, dual-cured resin luting cement that is exclusively formulated for luting crowns, bridges, inlays, onlays and posts (prefabricated metal and nonmetal/fiber posts, as well as cast posts). TheraCem is a paste/paste, fluoride- and calciumreleasing, luting cement which requires no etching, no priming or bonding of the prepared surfaces. It is easy-to use, requires only a short chair time, and produces a good bond to most dental materials. The cement is available in a Natural shade. It is radiopaque, allowing for easy identification on radiographs.

AI/ML Overview

The provided text is a 510(k) summary for the dental cement TheraCem. It describes the device, its indications for use, technological characteristics, and performance data, but it does not contain the information you're looking for regarding acceptance criteria and study details for an AI/CADe device.

Specifically, the document focuses on demonstrating substantial equivalence to predicate dental cements based on physical and mechanical properties, not on AI-assisted diagnostic or decision-making capabilities. Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: The document provides a table of physical/mechanical properties tested for TheraCem and states its equivalence to predicates or compliance with ISO standards, but these are not "acceptance criteria" in the context of an AI device's diagnostic performance (e.g., sensitivity, specificity, AUC).
Sample size used for the test set and the data provenance: Not applicable, as there's no diagnostic test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For a dental cement, "ground truth" would relate to its physical properties (e.g., bond strength, setting time), which are measured according to established standards (e.g., ISO).
The sample size for the training set: Not applicable, as there's no AI model being trained.
How the ground truth for the training set was established: Not applicable.

The document is for a medical device (dental cement) that does not involve AI or diagnostic imaging. The performance data presented is about the product's physical and chemical characteristics, which are compared to predicate devices for substantial equivalence.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 29, 2016

Bisco, Inc. Ryan Hobson RA Registration Coordinator 1100 West Irving Park Road Schaumburg, Illinois 60193

Re: K161256

Trade/Device Name: Theracem Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA, Dated: May 2, 2016 Received: May 4, 2016

Dear Ryan Hobson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K161256

Device Name TheraCem

Indications for Use (Describe)

Use TheraCem to cement the following:

1. Metal crowns, bridges, inlays and onlays (includes porcelain-fused-to-metal and composite-to-metal)
1. Porcelain, Ceramic Crowns, inlays and onlays (includes alumina and zirconia)
1. Resin crowns, bridges, inlays and onlays (resin-based composite-ceramic hybrid)
1. Metal (prefabricated or cast) and non-metal/fiber endodontic posts
1. Implant supported restorations
1. Orthodontic Appliances (brackets, bands)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for BISCO. The logo consists of five connected hexagons, with the first and last hexagons being red, the second and fourth being a gradient of red and blue, and the middle hexagon being blue. Below the hexagons is the word "BISCO" in a bold, sans-serif font, with the top half of the letters in gray and the bottom half in black.

510 (k) SUMMARY

Applicant:

Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193

Contact Person:

Ryan Hobson Tel: 847-534-6143 Fax: 847-534-6143

02 May 2016

Date Prepared:

Trade Name: Common Name: Product Code: Classification/Name:

TheraCem Self-Adhesive Resin Cement EMA Dental Cement Class II per 21 CFR 872.3275

Predicate Devices:

TheraCem is substantially equivalent to:

Primary Predicate:	BisCem by Bisco, Inc. K082449
Reference Predicate:	NuSmile Biocem by NuSmile, LTD / Pulpdent K123265

Indications for Use:

Use TheraCem to cement the following:

1. Metal crowns, bridges, inlays and onlays (includes porcelain-fused-to-metal and composite-to-metal)
Porcelain, Ceramic Crowns, inlays and onlays (includes alumina and zirconia) 2.
1. Resin crowns, bridges, inlays and onlays (resin-based composite-ceramic hybrid)
1. Metal (prefabricated or cast) and non-metal/fiber endodontic posts
1. Implant supported restorations
1. Orthodontic Appliances (brackets, bands)

BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.

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Image /page/4/Picture/0 description: The image shows the BISCO company logo. The logo consists of a series of connected, three-dimensional, hexagonal shapes in red and blue. Below the shapes, the word "BISCO" is written in a bold, sans-serif font, with the letters in gray and black.

510 (k) SUMMARY (continued)

The indications for use of TheraCem are the same as those for BisCem and NuSmile BioCem and are summarized in the table below:

	BisCem(K082449)	TheraCem	NuSmile BioCem(K123265)
	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)	Use TheraCem to cement the following:Metal crowns, bridges, inlays and onlays (includes porcelain-fused-to-metal and composite-to-metal) Porcelain, Ceramic Crowns, inlays and onlays (includes alumina and zirconia) Resin crowns, bridges, inlays and onlays (resin-based composite/composite-ceramic hybrid) Metal (prefabricated or cast) and non-metal/fiber endodontic posts Implant supported restorations Orthodontic Appliances (brackets, bands)	Pulpdent RMGI Low Viscosity is a resin-modified glass ionomer preparation used by dental professionals as a liner, base or luting material in dental restorations.

Description of Applicant Device:

BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.

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Image /page/5/Picture/0 description: The image shows the logo for BISCO. The logo consists of a series of connected, three-dimensional hexagonal shapes in red, light blue, and dark blue. Below the shapes is the word "BISCO" in a bold, sans-serif font, with the top half of the letters in gray and the bottom half in black.

510 (k) SUMMARY (continued)

Technological Characteristics:

All components of TheraCem are based upon industry standard chemistry. The chemical composition of TheraCem is similar to BisCem and BioCem and is summarized in the table below:

Chemical Composition	BisCem(K082449)	NuSmile BioCem(K123265)	TheraCem
Filler	Amorphous Silica	Amorphous Silica	Amorphous Silica &Portland Cement
Resin composition	Methacrylate based	Methacrylate based	Methacrylate based
Polymerization Method	Dual cured	Dual cured	Dual cured
Method of Application	Bonding agent notrequired	Bonding agent notrequired	Bonding agent notrequired
Ions Released	Fluoride	Calcium, phosphate, andfluoride	Calcium and fluoride

Physical MechanicalProperty	BisCem(K082449)	NuSmile BioCem(K123265)	TheraCem
Radiographic Appearance	Radiopaque	Radiopaque	Radiopaque
Ions Released	Fluoride releasing	Fluoride and calciumreleasing	Fluoride and calciumreleasing
Delivery system	Dual-syringe	Dual-syringe	Dual-syringe

The difference in filler is TheraCem's use of Portland cement, an industry standard chemical, to facilitate calcium release and is substantially equivalent in performance to amorphous silica. A reference predicate, BioCem (K123265), has been included to demonstrate substantial equivalence for calcium releasing.

BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.

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Image /page/6/Picture/0 description: The image shows the logo for BISCO. The logo consists of five connected hexagons, alternating between red and blue. Below the hexagons is the word "BISCO" in a bold, sans-serif font, with the letters in shades of gray and black.

510 (k) SUMMARY (continued)

Performance Data:

The following physical/mechanical properties of TheraCem were tested:

Physical / Mechanical Property	TheraCem
Bond Strength(Modified ISO 29022 andGel-Cap method)	TheraCem is equivalent to the predicates.
Diametral Tensile Strength	TheraCem is equivalent to the predicates.
Film Thickness(ISO 4049:2009)	TheraCem meets the requirements of ISO 4049:2009 for FilmThickness.
Flexural Strength(ISO 4049:2009)	TheraCem meets the requirements of ISO 4049:2009 forFlexural Strength.
Radiopacity(ISO 4049:2009)	TheraCem meets the requirements of ISO 4049:2009 forRadiopacity.
Working Time / Setting Time	TheraCem is equivalent to the predicates.
Compressive Strength	TheraCem is equivalent to the predicates.
Calcium Release	TheraCem is equivalent to the predicates.
Fluoride Release	TheraCem is equivalent to the predicates.

Biocompatibility:

An evaluation of biocompatibility was conducted using ISO 7405:2008 and ISO 10993-1 to determine the safety of TheraCem. It is concluded from the safety evaluation and the results of the Oral Toxicity Study (10 mice, 14 days) that TheraCem was not toxic in this test.

Conclusion:

It is concluded from review of the predicate device indications, chemical composition, biocompatibility, and physical properties that TheraCem is substantially equivalent to the predicate devices.

BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.

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.