1. Metal crowns, bridges, inlays (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)
1. Lining and basing applications under restorations

Device Description

TheraBase and TheraBase Ca are a self-etching, self-adhesive, dual-cured resin luting cement and base/liner that is exclusively formulated for luting crowns, bridges, inlays, onlays and posts (prefabricated metal and non-metal/fiber posts, as well as cast posts) and basing/lining under restorations. TheraBase is a paste/paste, fluoride- and calcium-releasing, luting cement and base/liner which requires no etching, no priming or bonding of the prepared surfaces. TheraBase Ca is a paste/paste, calcium-releasing, luting cement and base/liner which requires no etching, no priming or bonding of the prepared surfaces. They are easy-to use, require only a short chair time, and produce a good bond to most dental materials. The cements are available in a Natural shade. They are radiopaque, allowing for easy identification on radiographs.

AI/ML Overview

The document you provided is a 510(k) summary for a dental device, TheraBase / TheraBase Ca. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm or a comparative effectiveness study with human readers.

Instead, it presents performance data for the physical and mechanical properties of the dental cement, comparing them to established ISO standards or internal benchmarks.

Therefore, I cannot fulfill all parts of your request as it pertains to an AI/ML device with ground truth, expert adjudication, or MRMC studies. However, I can extract the relevant information regarding the device's physical and mechanical properties and present it in your requested format.

Here's the breakdown based on the provided document:

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

Physical / Mechanical Property	Acceptance Criteria (from document)	Reported Device Performance (TheraBase)	Reported Device Performance (TheraBase Ca)
Bond Strength	Higher than or equivalent to 6.9 MPa, and bond to all substrates (Modified ISO 29022 and Gel-Cap method)	Higher than or equivalent to 6.9 MPa, and bond to all the substrates.	Higher than or equivalent to 6.9 MPa, and bond to all the substrates.
Diametral Tensile Strength	Greater than or equal to 32 MPa	Greater than or equal to 32 MPa.	Greater than or equal to 32 MPa.
Film Thickness	< 50 µm (ISO 4049:2009 requirement)	< 35 µm	< 35 µm
Flexural Strength	Greater than the minimum flexural strength of 50 MPa (ISO 4049:2009)	Greater than the minimum flexural strength of 50 MPa.	Greater than the minimum flexural strength of 50 MPa.
Radiopacity	Greater than or equal to 2.0 (ISO 4049:2009)	Greater than or equal to 2.0.	Greater than or equal to 2.0.
Working Time / Setting Time	Working time: > 1 minute at room temperature (22±1°C)Setting time: < 5 minutes at 37±1°C	Working time: > 1 minute at room temperature (22±1°C)Setting time: < 5 minutes at 37±1°C	Working time: > 1 minute at room temperature (22±1°C)Setting time: < 5 minutes at 37±1°C
Compressive Strength	Equivalent to or greater than 189 MPa	Equivalent to or greater than 189 MPa.	Equivalent to or greater than 189 MPa.
Calcium Release	Greater than or equal to 3.3 µg Ca/cm²	Greater than or equal to 3.3 µg Ca/cm².	Greater than or equal to 3.3 µg Ca/cm².
Fluoride Release	(TheraBase only): Explicit criteria not stated, but "releases fluoride" is the performance metric.	Releases fluoride.	N/A (Does not contain fluoride)

Regarding the AI/ML specific questions:

Sample size used for the test set and the data provenance: Not applicable. This document describes physical material testing, not an AI/ML algorithm's performance on a test set of data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material properties are measured objectively according to standard protocols (e.g., ISO standards), not by expert consensus on data.
Adjudication method: Not applicable.
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 a dental cement, not an AI assistant for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable in the context of AI/ML. The "ground truth" for the material properties are the objective measurements obtained through standardized physical and chemical tests (e.g., ISO standards for film thickness, flexural strength, radiopacity).
The sample size for the training set: Not applicable. This document refers to a physical product, not a machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary of the study that proves the device meets the acceptance criteria (based on the document):

The device's performance was evaluated through a series of physical and mechanical property tests. These tests were conducted according to established industry standards such as ISO 29022 (modified), ISO 4049:2009, and the Gel-Cap method for bond strength. The document also mentions a Biocompatibility evaluation conducted using ISO 7405:2008 and ISO 10993-1, including an Oral Toxicity Study (10 mice, 14 days) which found the materials non-toxic.

The studies collectively demonstrated that both TheraBase and TheraBase Ca met or exceeded the specified acceptance criteria for each tested property (bond strength, diametral tensile strength, film thickness, flexural strength, radiopacity, working/setting time, compressive strength, calcium release, and fluoride release for TheraBase). The conclusion is that the devices are substantially equivalent to the predicate devices based on these chemical composition characteristics, biocompatibility, and physical properties.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Tuesday, March 17, 2020

Bisco, Inc. Diana Vu RA Registration Specialist 1100 West Irving Park Rd. Schaumburg, Illinois 60193

Re: K192007

Trade/Device Name: TheraBase / TheraBase Ca Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: December 19, 2019 Received: December 23, 2019

Dear Diana Vu:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Srivinas 'Nandu' Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192007

Device Name TheraBase / TheraBase Ca

Indications for Use (Describe)

1. Metal crowns, bridges, inlays (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)
1. Lining and basing applications under restorations

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)

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Image /page/3/Picture/1 description: The image shows the BISCO company logo. 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

Applicant:

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

Contact Person:

Diana Vu Tel: 847-534-6091 Fax: 847-534-6091

Date Prepared: 19 December 2019

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

TheraBase; TheraBase Ca Self-Adhesive Calcium Releasing Resin Cement and Base/Liner EMA Dental Cement Class II per 21 CFR 872.3275

Predicate Devices:

TheraCem is substantially equivalent to:

Primary Predicate:	TheraCem by Bisco, Inc. K161256
Reference Predicate:	NuSmile Biocem by NuSmile, LTD / Pulpdent K123265

Indications for Use:

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)
Resin crowns, bridges, inlays and onlays (resin-based composite-ceramic hybrid) 3.
1. Metal (prefabricated or cast) and non-metal/fiber endodontic posts
1. Implant supported restorations
Orthodontic Appliances (brackets, bands) 6.
Lining and basing applications under restorations 7.

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Image /page/4/Picture/1 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 blue, and the middle one being light blue. Below the hexagons is the word "BISCO" in gray and black lettering, with the bottom half of the letters being black.

510 (k) SUMMARY (continued)

The indications for use of TheraBase and TheraBase Ca are the similar to those for TheraCem and NuSmile BioCem and are summarized in the table below:

TheraCem(K161256)	TheraBase	TheraBase Ca	NuSmile BioCem(K123265)
Use TheraCem to cementthe following:1. Metal crowns,bridges, inlays andonlays (includesporcelain-fused-to-metal and composite-to-metal)2. Porcelain, CeramicCrowns, inlays andonlays (includesalumina and zirconia)3. Resin crowns,bridges, inlays andonlays (resin-basedcomposite/composite-ceramic hybrid)4. Metal (prefabricatedor cast) and non-metal/fiber endodonticposts5. Implant supportedrestorations6. OrthodonticAppliances (brackets,bands)	1. Metal crowns,bridges, inlays, onlays(includes porcelain-fused -to- metal andcomposite-to-metal)2. Porcelain, CeramicCrowns, inlays, andonlays (includesalumina and zirconia)3. Resin crowns,bridges, inlays, andonlays (resin-basedcomposite/composite-ceramic hybrid)4. Metal (prefabricatedor cast) and non-metal/fiber endodonticposts5. Implant supportedrestorations6. OrthodonticAppliances (brackets,bands)7. Lining and basingapplications underrestorations	1. Metal crowns,bridges, inlays, onlays(includes porcelain-fused -to- metal andcomposite-to-metal)2. Porcelain, CeramicCrowns, inlays, andonlays (includesalumina and zirconia)3. Resin crowns,bridges, inlays, andonlays (resin-basedcomposite/composite-ceramic hybrid)4. Metal (prefabricatedor cast) and non-metal/fiber endodonticposts5. Implant supportedrestorations6. OrthodonticAppliances (brackets,bands)7. Lining and basingapplications underrestorations	Pulpdent RMGI LowViscosity is a resin-modified glass ionomerpreparation used by dentalprofessionals as a liner,base or luting material indental restorations.

The only change in the indication for use from TheraCem to TheraBase and TheraBase Ca is the addition of "Lining and basing applications under restorations." NuSmile BioCem is added as a reference predicate to demonstrate that it does not raise new questions of safety and effectiveness as it contains the same indication listed as "liner, base."

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Image /page/5/Picture/1 description: The image shows the BISCO company logo on the left side of the image. The logo consists of a series of red and blue hexagons, followed by the word "BISCO" in large, bold letters. To the right of the logo, the text "510 (k) SUMMARY (continued)" is visible. The background of the image is white, with a faint pattern of hexagons in the upper right corner.

Description of Applicant Device:

Technological Characteristics:

All components of TheraBase and TheraBase Ca are based upon industry standard chemistry. The chemical composition of TheraBase is the same as TheraCem. The chemical composition of TheraBase Ca is similar to TheraCem. The chemical composition of TheraBase and TheraBase Ca is similar to NuSmile BioCem. The chemical compositon of each product is summarized in the table below:

ChemicalComposition	TheraCem(K161256)	NuSmile BioCem(K123265)	TheraBase	TheraBase Ca
Filler	Amorphous Silica &Portland Cement	Amorphous Silica	Amorphous Silica &Portland Cement	Amorphous Silica &Portland Cement
Resin composition	Methacrylate based	Methacrylate based	Methacrylate based	Methacrylate based
PolymerizationMethod	Dual cured	Dual cured	Dual cured	Dual cured
Method ofApplication	Bonding agent notrequired	Bonding agent notrequired	Bonding agent notrequired	Bonding agent notrequired
Ions Released	Calcium and fluoride	Calcium, phosphate,and fluoride	Calcium andfluoride	Calcium

Physical MechanicalProperty	TheraCem(K161256)	NuSmile BioCem(K123265)	TheraBase	TheraBase Ca
RadiographicAppearance	Radiopaque	Radiopaque	Radiopaque	Radiopaque
Ions Released	Fluoride andcalcium releasing	Fluoride andcalcium releasing	Fluoride andcalcium releasing	Calcium releasing
Delivery system	Dual-syringe	Dual-syringe	Dual-syringe	Dual-syringe

The difference in filler is TheraCem's, TheraBase's, and TheraBase Ca's additional use of Portland cement, an industry standard chemical, to facilitate calcium release and is substantially equivalent in performance to amorphous silica.

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Image /page/6/Picture/1 description: The image shows the logo for BISCO. The logo consists of a series of connected hexagons in red and blue, above the word "BISCO" in gray and black. The hexagons appear to be 3D, with shading to give them depth.

510 (k) SUMMARY (continued)

Performance Data:

The following physical/mechanical properties of TheraBase and TheraBase Ca were tested:
Physical / Mechanical Property	TheraBase	TheraBase Ca
Bond Strength(Modified ISO 29022andGel-Cap method)	TheraBase is higher than orequivalent to 6.9 MPa, and bondto all the substrates.	TheraBase Ca is higher than orequivalent to 6.9 MPa, and bondto all the substrates.
Diametral TensileStrength	TheraBase is greater than orequal to 32 MPa.	TheraBase Ca is greater than orequal to 32 MPa.
Film Thickness(ISO 4049:2009)	TheraBase is < 35 µm whichmeets the ISO 4049:2009requirement of < 50 µm.	TheraBase Ca is < 35 µm whichmeets the ISO 4049:2009requirement of < 50 µm.
Flexural Strength(ISO 4049:2009)	TheraBase is greater than theminimum flexural strength of 50MPa.	TheraBase Ca is greater than theminimum flexural strength of 50MPa.
Radiopacity(ISO 4049:2009)	TheraBase is greater than orequal to 2.0.	TheraBase Ca is greater than orequal to 2.0.
Working Time /Setting Time	TheraBase is greater than theminimum working time of 1 minuteat room temperature (22±1°C)and is less than the maximumsetting time of 5 minutes at37±1°C.	TheraBase Ca is greater than theminimum working time of 1 minuteat room temperature (22±1°C) andis less than the maximum settingtime of 5 minutes at 37±1°C.
CompressiveStrength	TheraBase is equivalent to orgreater than 189 MPa.	TheraBase Ca is equivalent to orgreater than 189 MPa.
Calcium Release	TheraBase releases calciumgreater than or equal to 3.3 µgCa/cm².	TheraBase Ca releases calciumgreater than or equal to 3.3 µgCa/cm².
Fluoride Release	TheraBase releases fluoride.	N/A, TheraBase Ca does notcontain fluoride

Biocompatibility:

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

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Image /page/7/Picture/1 description: The image shows the logo for BISCO. The logo consists of five connected hexagons, with the two outer hexagons being red and the three inner hexagons being blue. Below the hexagons is the word "BISCO" in a sans-serif font, with the top half of the letters being gray and the bottom half being black. The number 5 is in the bottom right corner of the image.

510 (k) SUMMARY (continued)

Conclusion:

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

800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com

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.