BIO-C REPAIR is a ready-to-use bioceramic MTA-based paste developed for permanent root canal repair and surgical applications. The product is a single paste provided in a syringe with disposable tips to be applied to the affected area of the root canal system. BIO-C REPAIR is an insoluble and radiopaque material which requires the presence of water to set and harden.

AI/ML Overview

The provided document is a 510(k) summary for the dental device BIO-C REPAIR. This document primarily focuses on establishing substantial equivalence to predicate devices based on comparisons of indications for use, technological characteristics, and performance data from bench testing. It does not describe a clinical study directly proving the device meets specific acceptance criteria in a clinical setting in the way an AI/ML device would.

However, based on the provided text, we can infer the acceptance criteria for various physical-chemical properties and present the reported device performance. No information is available regarding AI/ML specific criteria such as sensitivity, specificity, or accuracy, as this is a dental material, not an AI/ML diagnostic tool.

Here's the information extracted and formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the ISO 6876:2012 standard for dental root canal sealing materials and the properties of the predicate devices. The "reported device performance" refers to BIO-C REPAIR's measured characteristics.

Acceptance Criteria (Implicit from ISO 6876:2012 and Predicates)	Reported Device Performance (BIO-C REPAIR)
Non-sterile	Non-sterile
pH > 12	pH 12.5
Setting time ~ 2 hours (predicate reference)	Setting time 90 - 120 minutes
Radiopacity ≥ 7 mm Al	Radiopacity ≥ 7 mm Al
Biocompatible	Biocompatible
Shelf life 2 years	Shelf life 2 years
Solubility (in accordance with ISO 6876:2012 established values)	Values in accordance with ISO 6876:2012

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

The document does not specify a "test set" in the context of human data or AI/ML model evaluation. The performance data is derived from bench testing of the material itself. Therefore, sample sizes for the bench tests would refer to the number of material samples tested for properties like setting time, pH, radiopacity, and solubility. This information is not provided in the document.

Data provenance: The testing was performed by the manufacturer, Angelus Indústria de Produtos Odontológicos S/A, based in Londrina, Brazil. The data is from laboratory (bench) testing, not clinical. It is retrospective in the sense that the tests were completed before the 510(k) submission.

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

This is not applicable as the device is a dental material, not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for the material's properties is established through adherence to international standards (ISO 6876:2012) and comparison to predicate devices, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable as there is no "test set" requiring adjudication in the context of human expert review for a dental material. The performance measurements are objective laboratory tests.

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 is not applicable. The device is a dental filling material, not an AI-assisted diagnostic tool.

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

This is not applicable. The device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the properties of BIO-C REPAIR is established by objective laboratory measurements according to an international standard (ISO 6876:2012) and comparison to the characteristics reported for legally marketed predicate devices. This is analogous to "physical and chemical properties" ground truth.

8. The Sample Size for the Training Set

This is not applicable as the device is not an AI/ML model and therefore does not have a "training set."

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

This is not applicable. There is no training set for this type of device.

Summary

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

Angelus Industria de Produtos Odontologicos S/A Juliana Norder International Regulatory Affairs Analyst Rua Waldir Landgraf, 101 Londrina, 86.031-218 Br

Re: K180185

Trade/Device Name: BIO-C Repair Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: January 12, 2018 Received: January 23, 2018

Dear Juliana Norder:

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

August 31, 2018

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name BIO-C REPAIR

Indications for Use (Describe)

1. Furcation or root perforation treatment via canal;
1. Furcation or root perforation treatment via surgical;
1. Internal reabsorption treatment via canal or surgical;
1. External reabsorption treatment;
1. Retrofilling in parendodontic surgery;
1. Direct and indirect pulp capping;

Apexification;
Apexogenesis and Pulpotomy.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Angelus Indústria de Produtos Odontológicos S/A

BIO-C REPAIR

August 31, 2018

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Angelus Indústria de Produtos Odontológicos S/A
	Rua Waldir Landgraf, 101
	Londrina, PR 86031-218 Brazil
	Telephone: +55 (43) 2101-3200
	Fax: +55 (43) 2101-3201
Official Contact:	Juliana Norder
	International Regulatory Affairs Analyst

juliana.norder@angelus.ind.br

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	BIO-C REPAIR
Common Name:	Root Canal Filling Resin
Classification Regulation:	21 CFR 872-3820, Class II
Product Code:	KIF
Classification Panel:	Dental Products Panel
Reviewing Branch:	Dental Devices Branch
Primary Predicate Device:	K082943 iRoot BP (Innovative BioCeramix Inc.)
Secondary Reference Device:	K172701 BIO-C SEALER (Angelus Indústria de Produtos odontológicos S.A)

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DEVICE DESCRIPTION

PRODUCT PRESENTATION

Reference	Product Description	Package Contents
3863	BIO-C REPAIR	• 4 preloaded syringes with 0.5g each• 20 disposable intracanal tips

INTENDED USE

Reparative cement for endodontic complications.

INDICATIONS FOR USE

1. Furcation or root perforation treatment via canal;
1. Furcation or root perforation treatment via surgical;
1. Internal reabsorption treatment via canal or surgical;
1. External reabsorption treatment;
1. Retrofilling in parendodontic surgery;
1. Direct and indirect pulp capping;
1. Apexification;
1. Apexogenesis and Pulpotomy.

EQUIVALENCE TO MARKETED DEVICE

Angelus Indústria de Produtos Odontológicos S/A demonstrated that, for the purposes of FDA's regulation of medical devices, BIO-C REPAIR is substantially equivalent in indications and design principles to the following predicate device:

INNOVATIVE BIOCERAMIX INC., iRoot BP cleared under K082943

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The subject device and the predicate device have the same intended use and same technological characteristics and are made of similar materials. They encompass the same range of physical and chemical properties. The subject and predicate devices are packaged in similar materials and use similar methods of application.

Any differences in specific components do not raise new issues of safety or efficacy. Even though BIO-C REPAIR's main chemical composition is based on iRoot BP, as mentioned above, the additional chemical components in BIO-C REPAIR's composition and the delivery system were found in the following predicate device:

ANGELUS INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS S/A, BIO-C SEALER cleared under K172701.

COMPARISON TO THE CLEARED DEVICES

BIO-C REPAIR and iRoot BP are designated for the equivalent dental applications, have comparable chemical and physical properties and performance specifications. The secondary reference device, BIO-C SEALER, contains specific chemical components that are found in BIO-C REPAIR; providing evidence that these chemical components are safe and effective for medical device use and therefore does not affect the substantial equivalence. Furthermore, BIO-C REPAIR and BIO-C SEALER (K172701) have identical delivery systems (syringe and disposable intracanal tips).

The similarities and differences of BIO-C REPAIR and the predicates are discussed below:

BIO-C REPAIR, iRoot BP and BIO-C SEALER are mainly composed of tricalcium silicate and dicalcium silicate. These inqredients are responsible for physical and biological properties of both products.
Zirconium oxide is present in BIO-C REPAIR, iRoot BP and BIO-C SEALER compositions. This ingredient is responsible for the radiopacity of the products.
BIO-C REPAIR and BIO-C SEALER uses calcium oxide as Ca²+ an OH sources while iRoot BP relies only on calcium silicates to provide calcium and hydroxyl ions.
BIO-C REPAIR and BIO-C SEALER share the same dispersing agent, while iRoot BP does not discloses its carrier.
く iRoot BP also contains calcium phosphate monobasic and tantalum pentoxide, unlike BIO-C REPAIR and BIO-C SEALER.
BIO-C REPAIR, iRoot BP and BIO-C SEALER share the same Delivery System (syringe and > disposable intracanal tips).

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Therefore, it is concluded that BIO-C REPAIR is substantially equivalent to the predicate devices.

The table below summarizes the main similarities of BIO-C REPAIR and the predicate devices:

Element	Proposed Device	Predicate Device(K082943)	ReferenceDevice
			(K172701)
Trade Name	BIO-C REPAIR	iRoot BP	BIO-C SEALER
Manufacturer	ANGELUS INDÚSTRIA DEPRODUTOSODONTOLÓGICOS S/A	INNOVATIVE BIOCERAMIXINC.	ANGELUS INDÚSTRIA DEPRODUTOSODONTOLÓGICOS S/A
Device Description	BIO-C REPAIR is a ready-to-use bioceramicreparative cement.	iRoot BP Injectable RootCanal Repair FillingMaterial is a convenientready-to-use whitehydraulic premixedinjectable paste developedfor permanent root canalrepair and fillingapplications.	BIO-C SEALER is a ready-to-use injectableendodontic bioceramicSealer, suitable forobturation of root canals.
Common Name	Root Canal Filling Resin	Root Canal Filling Resin	Root Canal Filling Resin
Class	Class II	Class II	Class II
Product Code	KIF	KIF	KIF
Composition	Calcium silicatesCalcium oxideZirconium oxideSilicon oxideIron oxideDispersing agent	Tricalcium silicateDicalcium silicateCalcium phosphatemonobasicZirconium oxideTantalum PentoxideFiller agents	Calcium silicatesCalcium oxideZirconium oxideSilicon oxideIron oxideDispersing agent
Principle ofoperation	BIO-C REPAIR is aninsoluble and radiopaqueroot repair material whichrequires the presence ofwater to set and harden.Calcium hydroxide isproduced due to thehydration reaction of thecalcium silicates andcalcium oxide increasingthe pH of the medium.	iRoot BP is a ready-to-usewhite hydraulic premixedinjectable paste developedfor permanent root canalrepair and fillingapplications. iRootBP is an insoluble,radiopaque and aluminum-free material based on acalcium silicatecomposition, whichrequires the presence ofwater to set and harden.iRoot BP does not shrinkduring setting and ispackaged in a preloadedsyringe and is suppliedwith disposable tips.	BIO-C SEALER is aninsoluble and radiopaqueroot canal sealer whichrequires the presence ofwater to set and harden.Calcium hydroxide isproduced due to thehydration reaction of thecalcium silicates andcalcium oxide increasingthe pH of the medium.
Indications for use	1. Furcation or rootperforation treatment viacanal;2. Furcation or rootperforation treatment viasurgical;3. Internal reabsorptiontreatment via canal orsurgical;4. External reabsorptiontreatment;	Repair of Root PerforationRepair of Root ResorptionRoot End FillingApexificationPulp Capping	Sealing the root canal ofpermanent teeth;Internal reabsorptiontreatment.
Delivery form	Single paste	Single paste	Single paste
Design	SyringeDisposable Intra Canal tips	SyringeDisposable Intra Canal tips	SyringeDisposable Intra Canal tips
Nature of contact	Category: Externalcommunicating deviceContact: Tissue, bone anddentinContact Duration: C -Permanent (>30 days)	Category: Externalcommunicating deviceContact: Tissue, bone anddentinContact Duration: C -Permanent (>30 days)	Category: Externalcommunicating deviceContact: Tissue, bone anddentinContact Duration: C -Permanent (>30 days)
Sterile	Non-sterile	Non-sterile	Non-sterile
pH	12.5	> 12	12.5
Setting time	90 - 120 minutes	~ 2 hours	120-240 minutes
Radiopacity	$\ge$ 7 mm Al	~ 7 mm Al	$\ge$ 7 mm Al
Biocompatibility	Biocompatible	Biocompatible	Biocompatible
Contraindications	Do not use it in patientsthat report sensitivity tothe components of theformula.	Do not use in patientswith a known allergy toany of the product'singredients.	Do not use it in patientsthat report sensitivity tothe components of theformula.
Shelf Life	2 years	2 years	2 years
Environment of use	Prescription / Hospital	Prescription / Hospital	Prescription / Hospital
Intendedenvironment	Dental offices	Dental offices	Dental offices
Intended users	Dental practitioners	Dental practitioners	Dental practitioners
Intended patientpopulation	Patients who requireendodontic treatment.	Patients who requireendodontic treatment.	Patients who requireendodontic treatment.
Storage	Keep the product in a dryand ventilated placebetween 15 and 30°C andwith relative humiditybelow 60%.Do not store it in arefrigerator.Do not store the productnear ammonia,ammonium nitrate andproducts containingchlorine. Avoid usingdisinfectant solutions thatcontain any of theseingredients.	- Keep tightly closed in itssealed package and storeit at room temperature ina dry area, to avoidmoisture contact, whichcould induce the settingprocess.- Be certain to tightlysecure the lid of the jarafter each use.- Use the syringe cap tokeep the syringe tightlyclosed when not using thematerial.- Do not use excessiveforce to apply the materialinto the root canal, as thismay cause acute pain to	Keep the product in a dryand ventilated placebetween 15 and 30°C andwith relative humiditybelow 60%.Do not store it in arefrigerator.Do not store the productnear ammonia,ammonium nitrate andproducts containingchlorine. Avoid usingdisinfectant solutions thatcontain any of theseingredients.

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PERFORMANCE DATA OR NON-CLINICAL EVIDENCE

BIO-C REPAIR has undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to iRoot BP. The following bench tests were performed according to ISO 6876:2012 Dental root canal sealing materials: setting time, solubility and radiopacity.

Both devices are provided non-sterile and have comparable setting time, pH and radiopacity. Although we did not find the solubility of the predicate, our product when subjected to solubility tests presented values in accordance with the established by the international standard.

CONCLUSION

BIO-C REPAIR and its predicate device are designated for equivalent dental applications and have comparable chemical and physical properties and performance specifications. Furthermore, BIO-C REPAIR and its predicate device have equivalent shelf life, packaging containers and delivery systems.

Based on the information provided in the premarket notification, we can conclude that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.