Pulpotomy
Temporary Filling Material
Repair of Root Perforations
Repair of Furcation Perforations
Repair of Perforating Internal and External Resorptions
Root-End Filling in Endodontic Surgery
Pulp Exposures (Direct Pulp Capping)
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

This document is a 510(k) summary for TheraCal DC, a dental restorative material. The purpose of a 510(k) is to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device. This document does not describe a study involving an AI-powered diagnostic device, but rather a dental material. Therefore, many of the requested categories for AI device studies are not applicable.

Here's an attempt to extract relevant information and note the inapplicable categories:

1. Table of Acceptance Criteria and Reported Device Performance

The document compares the "Modified TheraCal DC" (the subject device) to the "TheraCal DC (K143292)" (the predicate device). The acceptance criteria are essentially that the modified device performs equivalently to the predicate in key physical and mechanical properties.

Characteristic / Property	Acceptance Criteria	Subject Device Performance (Modified TheraCal DC)
Indications for Use	Identical to predicate device (K143292)	Identical to predicate device (K143292), including pulpotomy, temporary filling, repair of perforations, etc.
Material / Chemical Composition	Chemically equivalent to predicate device	- Filler: Portland Cement (same as predicate)- Resin Composition: Hydrophilic resin to facilitate calcium release (same as predicate)- Method of polymerization: Dual-Cure (same as predicate)- Method of Application: bonding agent not required (same as predicate)- Ions Released: Calcium and hydroxide (same as predicate)
Radiographic Appearance	Radiopaque (same as predicate - ISO 4049:2009 7.14)	Radiopaque
Ions Released (Property)	Calcium releasing (same as predicate)	Calcium releasing
pH	Basic (same as predicate)	Basic
Shelf-Life	Improved shelf-life over predicate (predicate was 12 months)	18 months (predicate was 12 months, this is an improvement)
Physical/Mechanical Properties	Equivalent performance to predicate in: Flexural strength, Compressive strength, Dimetral tensile strength, Working time, Bond strength, Radiopacity, Water sorption and solubility, Calcium release, pH.	Direct comparison testing demonstrates that TheraCal DC is equivalent to the predicate device. (Specific values not provided in this summary, but implied to meet equivalence.)
Biocompatibility	Meets requirements of ISO 7405:2008 and ISO 10993-1:2009	An evaluation was conducted using these standards, and it is concluded that TheraCal DC meets the requirements of the testing.

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

Sample size: Not specified. The document states "direct comparison testing" and "evaluated" for physical/mechanical properties and biocompatibility, but the exact sample sizes for each test are not listed in this summary.
Data provenance: Not specified, but standard ISO/ANSI/ADA test methods are referenced, implying laboratory testing. The company, Bisco, Inc., is based in Schaumburg, Illinois, USA. The testing would presumably have been conducted in a lab environment. The study is prospective in the sense that the testing was performed specifically to support this 510(k) application for the modified device.

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

Not applicable. This is a material science study, not a clinical study requiring expert interpretation of results. The "ground truth" is established by adherence to recognized international and national standards for material testing (e.g., ISO 4049, ANSI/ADA Spec. No. 27, ISO 7405, ISO 10993).

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

Not applicable. This is not a study requiring adjudication of expert opinions.

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 diagnostic device.

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

Not applicable. This is not an AI diagnostic device.

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

The "ground truth" for the material's properties is defined by objective physical and mechanical measurements according to established international and national standards (e.g., ISO 4049:2009 for flexural strength and radiopacity, ANSI/ADA Spec. No. 27:1993 for compressive strength, ISO 7405:2008 and ISO 10993-1:2009 for biocompatibility).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The Department of Health & Human Services logo is a stylized image of a human figure.

April 5, 2018

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

Re: K180344

Trade/Device Name: TheraCal DC Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: Class II Product Code: EJK Dated: March 5, 2018 Received: March 7, 2018

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 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);

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S

for 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) K180344

Device Name TheraCal DC

Indications for Use (Describe)

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

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/0 description: The image shows the logo for BISCO. Above the name are five connected hexagons. The first and last hexagons are red, while the middle three are blue. The name BISCO is written in a sans-serif font, with the top half of the letters in gray and the bottom half in black.

Special 510(k) SUMMARY

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

Contact Person:

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

5 March 2018

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 DC by Bisco Inc. K143292 Primary Predicate:

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

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

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Image /page/4/Picture/0 description: The image shows the BISCO company logo. The logo consists of five connected hexagons, with the first and last hexagons being red, the second and fourth being blue, and the middle hexagon being light blue. Below the hexagons is the word "BISCO" in a gray, sans-serif font, with the bottom half of the letters being black.

Special 510(k) SUMMARY (continued)

The indications for use of TheraCal DC are identical to the predicate device.

TheraCal DC	Modified TheraCal DC
(K143292)
TheraCal DC is indicated for use for:	TheraCal DC is indicated for use for:
1. Pulpotomy	1. Pulpotomy
2. Temporary filling material	2. Temporary filling material
3. Repair of root perforations	3. Repair of root perforations
4. repair of furcation perforations	4. repair of furcation perforations
5. repair of perforating internal and external resorptions	5. repair of perforating internal and external resorptions
6. apexification	6. apexification
7. root-end filling in endodontic surgery	7. root-end filling in endodontic surgery
8. pulp exposures (direct pulp capping)	8. pulp exposures (direct pulp capping)

Description of Applicant Device:

Technological Characteristics:

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

Chemical Composition	TheraCal DC(K143292)	Modified TheraCal DC
Filler	Portland Cement	Portland Cement
Resin Composition	Hydrophilic resin to facilitate calciumrelease	Hydrophilic resin to facilitate calciumrelease
Method of polymerization	Dual-Cure	Dual-Cure
Method of Application	bonding agent not required	bonding agent not required
Ions Released	Calcium and hydroxide	Calcium and hydroxide

Physical / Mechanical Property Comparison	TheraCal DC(K143292)	Modified TheraCal DC
Radiographic Appearance(ISO 4049:2009 7.14)	Radiopaque	Radiopaque
Ions Released	Calcium releasing	Calcium releasing
pH	basic	basic
Shelf-Life	12 months	18 months

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

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Image /page/5/Picture/0 description: The image shows the logo for BISCO. The logo consists of five connected hexagons in a row. The first, third, and fifth hexagons are red, while the second and fourth hexagons are blue. Below the hexagons is the word "BISCO" in a sans-serif font, with the top half of the letters in gray and the bottom half in black.

The primary difference between the subject device and the predicate is the stated shelf life.

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 (in-house 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 equivalent to the predicate device.

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 from review of the predicate device indications, chemical composition, biocompatibility, and physical properties that TheraCal DC is substantially equivalent in safety and effectiveness to the predicate device.

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

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.