1. Pulpotomy
1. Temporary filling material
1. Repair of root perforations
Repair of furcation perforations 4.
1. Repair of perforating internal and external resorptions
1. Root-end filling in endodontic surgery
1. Pulp exposures (direct pulp capping)
1. Protective liner (Indirect Pulp Capping) and Base for use under a variety of substrates

Device Description

TheraCal DC is a biocompatible, dual-cured, resin-modified calcium silicate that is used to treat damaged dentin in both the crown and the root. TheraCal DC's precise placement allows its use in all deep cavity preparations and endodontic repairs. The dual-cure set permits immediate placement and condensation of the restorative material. Its proprietary formulation allows for a command set with a light curing unit while maintaining ease of placement due to its thixotropic properties.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the TheraCal DC device, extracted from the provided text:

Important Note: The provided document is a 510(k) summary for a dental material (TheraCal DC), not a software or AI-driven medical device. Therefore, many of the requested categories like "test set size," "ground truth experts," "adjudication method," "MRMC study," and "standalone performance" are not applicable in the context of this device and its regulatory submission. The information below reflects what is available in the document for a physical material.

1. Table of Acceptance Criteria and Reported Device Performance

Physical/Mechanical Property	Acceptance Criteria (Implied / Comparator)	Reported Device Performance for TheraCal DC
Flexural Strength	Comparable to or greater than predicate devices	Greater than the predicate devices
Dimetral Tensile Strength	Comparable to or greater than predicate devices	Greater than the predicate devices
Working Time	Met design control inputs	Met the design control inputs
Bond Strength (Shear)	Comparable to or greater than predicate devices	Greater than the predicate devices
Radiopacity (ISO 4049:2009 7.14)	Meets ISO requirements (1 mm > 1mm of alumina)	Meets the ISO requirements
Water Sorption (ISO 4049:2009)	Meets ISO 4049 requirements	Meets the ISO 4049 requirements
Water Solubility (ISO 6876:2012)	Meets ISO 6876 requirements	Meets the ISO 6876 requirements
Calcium Release	Equivalent to predicate devices	Equivalent to the predicate devices
pH Testing	Equivalent to predicate devices	Equivalent to the predicate devices
Biocompatibility (ISO 7405:2008 & ISO 10993-1:2009)	Meets requirements of testing	Met the requirements of the testing

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

Sample Size for Test Set: Not specified. This document summarizes and compares physical/mechanical properties and biocompatibility, which typically involve laboratory tests on material samples rather than a "test set" in the sense of patient data.
Data Provenance: Not specified. The tests are "in-house test method" or reference ISO/ANSI/ADA standards, suggesting laboratory testing. No information on country of origin or retrospective/prospective nature is relevant for this type of device.

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

Number of Experts: Not applicable. Ground truth for material properties is established through standardized laboratory testing methods, not expert consensus on interpretations.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Material property testing does not typically involve adjudication.

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

MRMC Study: No, this is not an AI-driven device.

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

Standalone Study: No, this is not an AI-driven device.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for the performance data mentioned is established through standardized laboratory test methods (e.g., ISO, ANSI/ADA standards) and direct comparison to legally marketed predicate devices. For biocompatibility, it's defined by compliance with ISO standards (ISO 7405:2008 and ISO 10993-1:2009).

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. There is no "training set" in the context of a physical dental material. The material is developed and formulated based on scientific principles and then tested against established standards and predicate devices.

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

How Ground Truth for Training Set Was Established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the outlines of the faces visible.

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

August 4, 2015

Bisco Inc. Ms. Michelle Schiltz-Taing Regulatory Affairs Product Registration Manager 1100 West Irving Park Road Schaumburg, Illinois 60193

Re: K143292

Trade/Device Name: TheraCal DC Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: II Product Code: EJK Dated: June 24, 2015 Received: June 26, 2015

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. 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.

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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 device-related 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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.

Tina
Kiang -S

for Erin I. Keith, M.S. 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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510 (k) Number (if known): _ K143292

Device Name: _ TheraCal DC

Indications for Use:

TheraCal DC is indicated for use for:

1. Pulpotomy
1. Temporary filling material
1. Repair of root perforations
Repair of furcation perforations 4.
1. Repair of perforating internal and external resorptions
1. Root-end filling in endodontic surgery
1. Pulp exposures (direct pulp capping)
1. Protective liner (Indirect Pulp Capping) and Base for use under a variety of substrates

Prescription Use (Part 21 CFR 801 Subpart D)

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)

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Image /page/3/Picture/0 description: The image shows the logo for BISCO. The logo consists of a series of five interconnected geometric shapes in red and blue, arranged horizontally. Below the shapes is the word "BISCO" in a bold, sans-serif font, with the letters in gray and black.

510 (k) SUMMARY

Applicant:
------------

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

Contact Person:

Michelle Schiltz-Taing Tel: 847-534-6146 Fax: 847-534-6146

03 August 2015

Date Prepared:

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

TheraCal DC Dual-Cured Resin-Modified Calcium Silicate Pulp Protectant EJK Liner, Cavity, Calcium Hydroxide Class II per 21 CFR 872.3250

Predicate Devices:

TheraCal DC is substantially equivalent to:

TheraCal LC by Bisco Inc. K063237 Primary Predicate: Reference Predicates: BioDentine by Septodont K140132 RMGI Low Viscosity (believed to be Activa) by Pulpdent K123265 Pro Root MTA by Dentsply K142178

TheraCal DC is indicated for use for:

1. Pulpotomy
1. Temporary Filling Material
1. Repair of Root Perforations
1. Repair of Furcation Perforations
1. Repair of Perforating Internal and External Resorptions
1. Root-End Filling in Endodontic Surgery
1. Pulp Exposures (Direct Pulp Capping)
1. Protective Liner (Indirect Pulp Capping) and Base for Use Under a Variety of Substrates

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

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510 (k) SUMMARY (continued)

The indications for use of TheraCal DC are the same as those for its predicates and are summarized in the table below:

TheraCal LCK063237	ActivaK123265	ProRoot MTAK142178	BioDentineK140132	TheraCal DC
1. Liner2. Pulp Capping Agent	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	root end filling material for the repair of repair of root canals as an apical plug during apexification for the repair of root perforations during root canal therapy or as a consequence of internal resorption as a pulp capping material pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations	Biodentine is indicated to be used:In the crown:-permanent dentine restoration under composites or inlay/onlay-temporary dentine-enamel restoration-restoration of deep and/or large coronal carious lesions (sandwich technique)-restoration of cervical radicular lesions.-pulp capping.-pulpotomy.In the root:-repair of root perforations-repair of furcation perforations-repair of perforating	TheraCal DC is indicated for use for:1. Pulpotomy2. Temporary filling material3. Repair of root perforations4. repair of furcation perforations5. repair of perforating internal and external resorptions6. root-end filling in endodontic surgery7. pulp exposures (direct pulp capping)8. Protective liner (indirect pulp capping) and base for use under a variety of substrates

Description of Applicant Device:

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Image /page/5/Picture/0 description: The image shows the logo for BISCO. The logo features a series of connected, three-dimensional hexagonal shapes in red and blue. Below the shapes is the word "BISCO" in large, bold, gray letters with a glossy effect.

Technological Characteristics:

All components of TheraCal DC are based upon industry standard chemistry. Comparisons of the chemical composition of TheraCal DC to the predicates are provided in the following table:

Chemical Composition	TheraCal LCK063237	ActivaK123265	TheraCal DC
Filler	Portland Cement	Amorphous Silica	Portland Cement
Resin Composition	Hydrophilic resin tofacilitate calcium release	Blend of diurethane and othermethacrylates with modifiedpolyacrylic acid	Hydrophilic resin tofacilitate calcium release
Method of polymerization	Light-Cure	Dual-Cure	Dual-Cure
Method of Application	Bonding agent not required	Bonding agent not required	Bonding agent not required
Ions Released	Calcium and hydroxide	Calcium, phosphate, and fluoride	Calcium and hydroxide

Physical / Mechanical PropertyComparison	TheraCal LCK063237	ActivaK123265	BioDentineK140132	TheraCal DC
Radiographic Appearance(ISO 4049:2009 7.14)	Radiopaque	Radiopaque	Radiopaque	Radiopaque
Ions Released	Calcium releasing	Fluoridecontaining	Calciumreleasing	Calcium releasing
pH	basic	Not reported	basic	basic

The difference in chemical composition as compared to the primary predicate is the addition of industry standard chemicals to make TheraCal DC dual-curable. A reference predicate has been provided that is also dual-cured (Activa).

Performance Data:

The following physical/mechanical properties of TheraCal DC were tested: flexural strength (ISO 4049:2009), compressive strength (ANSI/ADA Spec. No. 27:1993 Appendix A2), dimetral tensile strength (in-house test method), working time (in-house test method), bond strength (inhouse test method), radiopacity (ISO 4049:2009), water sorption and solubility (ISO 4049:2009 and ISO 6876:2012), calcium release (in-house test method), and pH (in-house test method). An evaluation of biocompatibility of TheraCal DC was conducted using ISO 7405:2008 and ISO 10993-1:2009. Direct comparison testing demonstrates that TheraCal DC is similar to or greater than the predicate devices.

Physical / Mechanical Property	TheraCal DC
Flexural Strength	TheraCal DC is greater than the predicate devices
Dimetral Tensile Strength	TheraCal DC is greater than the predicate devices
Working Time	Not compared to predicate devices; met the design control inputs
Bond Strength	TheraCal DC shear bond strength is greater than the predicate devices
Radiopacity	Meets the ISO requirements (1 mm of TheraCal DC > 1mm of alumina)
Water Sorption & Solubility	TheraCal DC meets the ISO 4049 requirements for water sorption
	TheraCal DC meets the ISO 6876 requirements for water solubility
Calcium Release	TheraCal DC is equivalent to the predicate devices
pH Testing	TheraCal DC is equivalent to the predicate devices

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Image /page/6/Picture/0 description: The image shows the BISCO company logo. The logo consists of five connected hexagons, with the first two being red, the third being blue, and the last two being red. Below the hexagons is the word "BISCO" in a bold, sans-serif font, with the top half of the letters being gray and the bottom half being black.

It is concluded from the evaluation and the results of the cytotoxicity study that TheraCal DC meets the requirements of the testing.

Conclusion:

It is concluded that the information supplied in this submission has demonstrated that TheraCal DC is substantially equivalent to the legally marketed predicate devices because:

. The indications for use are the same to the listed predicates,
. The chemical composition, method of application and method of polymerization is similar to the primary and reference predicate devices.
. Physical properties are equivalent to the predicates.
The requirements of the biological testing were met. ●

Regulation Number and Section

§ 872.3250 Calcium hydroxide cavity liner.

(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.