BIO-C REPAIR ION+ is a bioceramic reparative material ready-to-use suitable for furcation or root perforation treatment via canal, furcation treatment via surgical, internal reabsorption treatment via canal or surgical, external reatment, retrofilling in parendodontic surgery, direct and indirect pulp capping, apexification, apexogenesis and pulpotomy.
The product is a single paste provided in a syringe with blunt tips to be applied into the root canal system. BIO-C REPAIR ION* is an insoluble and alkaline material, which requires the presence of water to set and harden. The product presents suitable radiopacity, demonstrating adequate physical properties inherent to root repair materials.

AI/ML Overview

This document describes the marketing authorization for the Bio-C Repair Ion+ dental device. It does not contain information about the acceptance criteria or study details as typically associated with AI/ML-based medical devices. The device is a traditional dental material, not an AI or ML product. Therefore, I cannot provide an answer that includes details such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

However, I can extract the information relevant to the non-clinical performance testing conducted for this device.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Internal/ISO Standard)	Reported Device Performance for BIO-C REPAIR ION+
Physical/Chemical Properties
Setting Time (ISO 6876:2012)	90-120 minutes	90-120 minutes
Solubility (ISO 6876:2012)	Not explicitly stated in the document as a numerical acceptance criterion, but implied as meeting the standard's requirements for "insoluble".	Meets the standard's requirements for being insoluble
Radiopacity (ISO 6876:2012)	Not explicitly stated as a numerical acceptance criterion in the text, but the reported performance for the predicate deviceBIO-C SEALER ION+ is "≥ 7 mm Al," and for BIO-C REPAIR and BIO-C REPAIR ION+ it's "~ 7 mm Al". It is implied that BIO-C REPAIR ION+ meets comparable radiopacity.	~ 7 mm Al
Injectability	Incorporated into product acceptance criteria (no specific value provided).	Test performed and reported to meet criteria.
X-ray diffraction	Incorporated into product acceptance criteria (no specific details provided).	Test performed and reported to meet criteria.
Particle size distribution	Incorporated into product acceptance criteria (no specific details provided).	Test performed and reported to meet criteria.
Color determination analyses	Incorporated into product acceptance criteria (no specific details provided).	Test performed and reported to meet criteria.
pH	> 10	> 10
Biocompatibility (ISO 10993-1:2009)
Sensitization	Non-sensitizing	Non-sensitizing
Irritation	Non-irritant	Non-irritant to oral mucosa of hamsters
Mutagenicity (Genotoxicity)	Non-mutagenic and did not induce genotoxic effects to bone marrow cells of mice. (This refers to data from predicate devices, which is deemed sufficient due to compositional similarity.)	Met requirements, based on predicate device data.
Acute Systemic Toxicity	Absence of acute systemic toxicity after single oral administration. (This refers to data from predicate devices, which is deemed sufficient due to compositional similarity.)	Met requirements, based on predicate device data.
Local and Systemic Toxic Effects upon Implantation	Did not demonstrate local and systemic toxic effects when implanted. (This refers to data from predicate devices, which is deemed sufficient due to compositional similarity.)	Met requirements, based on predicate device data.
Overall Biocompatibility	Biocompatible according to ISO 10993-1:2009	Biocompatible according to ISO 10993-1:2009

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

This information is not provided in the document as it pertains to a traditional material device, not software, AI, or ML. The document refers to "extensive bench testing" and biological evaluations according to ISO standards, which typically involve specific numbers of samples or animals as defined by those standards. The data provenance (country of origin or retrospective/prospective nature) is not specified.

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 document describes a material device and evaluates its physical, chemical, and biological properties, not diagnostic or predictive performance requiring expert ground truth setting like an AI/ML device.

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

Not applicable for a physical material device.

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 device is a dental material, not an AI or ML system intended to assist human readers.

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

Not applicable. This device is a dental material.

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

For the non-clinical tests, the "ground truth" is defined by the objective measurements and methodologies outlined in the ISO standards (ISO 6876:2012 for physical properties and ISO 10993-1:2009 for biocompatibility). For example, setting time is measured by a specific physical method, and cytotoxicity is assessed via laboratory assays, not expert consensus or pathology in a clinical setting.

8. The sample size for the training set

Not applicable for a physical material device.

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

Not applicable for a physical material device.

Summary

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February 11, 2021

Angelus Industria de Produtos Odontologicos S/A Juliana Trostdorf International Regulatory Affairs Coordinator Rua Waldir Landgraf, 101 Londrina, PR 86.031-218 BRAZIL

Re: K201222

Trade/Device Name: Bio-C Repair Ion+ Regulation Number: 21 CFR 872.3820 Regulation Name: Root canal filling resin Regulatory Class: Class II Product Code: KIF Dated: November 19, 2020 Received: November 19, 2020

Dear Juliana Trostdorf:

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

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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 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 (OS) 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,

Michael E. Adjodha, M.ChE. Assistant 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K201222

Device Name BIO-C REPAIR ION+

Indications for Use (Describe)

· Furcation or root perforation treatment via canal;
· Furcation or root perforation treatment via surgical;
· Internal reabsorption treatment via canal or surgical;
· External reabsorption treatment;
· Retrofilling in parendodontic surgery;
· 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 ION+

K201222

ADMINISTRATIVE INFORMATION

Date prepared:	April 30th, 2020.
Manufacturer Name:	Angelus Indústria de Produtos Odontológicos S/ARua Waldir Landgraf, 101Londrina, PR 86031-218 BrazilTelephone: +55 (43) 2101-3200Fax: +55 (43) 2101-3201
Official Contact:	Juliana Norder TrostdorfRegulatory Affairs Coordinatorjuliana.norder@angelus.ind.br

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	BIO-C REPAIR ION+
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:	K180185 BIO-C REPAIR (Angelus Indústria deProdutos Odontológicos S/A)
Reference Device:	K190537 BIO-C SEALER ION+ (Angelus Indústria deProdutos Odontológicos S/A)

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DEVICE DESCRIPTION

The product is a single paste provided in a syringe with blunt tips to be applied into the root canal system. BIO-C REPAIR ION* is an insoluble and alkaline material, which requires the presence of water to set and harden. The product presents suitable radiopacity, demonstrating adequate physical properties inherent to root repair materials.

Reference	Product Description	Package Contents
3912	BIO-C REPAIR ION+	1 syringe with 0.5 g
3913	BIO-C REPAIR ION+	2 syringes with 0.5 g
3914	BIO-C REPAIR ION+	4 syringes with 0.5 g

PRODUCT PRESENTATION

INTENDED USE

Reparative material 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.

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COMPARISON OF TECHNOLOGY

BIO-C REPAIR ION+ and BIO-C REPAIR are indicated for equivalent dental applications, have comparable chemical/physical properties and performance specifications and equivalent delivery systems (ready-to-use syringe). The reference device, BIO-C SEALER ION+, contains the same chemical components that is found in BIO-C REPAIR ION+;

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

V BIO-C REPAIR ION*, BIO-C REPAIR and BIO-C SEALER ION* are mainly composed of calcium silicates. BIO-C REPAIR ION+ and BIO-C SEALER ION* are composed of calcium and magnesium silicate, and BIO-C REPAIR is composed of calcium silicates. Despite the difference between the silicates in the formulations, biocompatibility tests were conducted with BIO-C REPAIR and BIO-C SEALER ION' and the results demonstrated that the devices are biocompatible.
V BIO-C REPAIR ION+ and BIO-C SEALER ION* uses calcium sulfate as setting agent, whereas BIO-C REPAIR sets in the presence of moisture due to the hydration of the calcium silicates.
V As BIO-C REPAIR ION+, BIO-C REPAIR and BIO-C SEALER ION+ are pre-mixed ready-to-use pastes, a biocompatible hydrophilic polymer is used in order to give an adequate viscosity and flow to the products. In this case, this polymer is included as a chemical component in all three materials and is also present in several cleared dental devices.
v Zirconium oxide is present in all three compositions. This component is responsible for the radiopacity of the products.
√ BIO-C REPAIR ION+, BIO-C REPAIR and BIO-C SEALER ION+ use fumed silica (silicon oxide) as rheometry agent. This component is inert and the percentage of fumed silica used in all devices are highly similar.
V All materials share the same delivery system (ready-to-use syringe).
v All materials are provided non-sterile and have comparable setting time, solubility and radiopacity.

BIO-C REPAIR ION+, BIO-C REPAIR and BIO-C SEALER ION+ are available as pre-mixed ready-to-use radiopaque pastes essentially designated for the equivalent dental applications and have comparable physical properties, performance specifications and share specific chemical components as can be seen above.

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

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Element	Proposed Device	Predicate Device(K180185)	Reference Device(K190537)	Discuss / Justify theDifferences
Trade Name	BIO-C REPAIR ION+	BIO-C REPAIR	BIO-C SEALER ION+
Manufacturer	ANGELUS INDÚSTRIA DE PRODUTOSODONTOLÓGICOS S/A	ANGELUS INDÚSTRIA DEPRODUTOS ODONTOLÓGICOSS/A	ANGELUS INDÚSTRIA DEPRODUTOS ODONTOLÓGICOS S/A	-
Device Description	BIO-C REPAIR ION+ is a ready-to-usebioceramic reparative material forendodontic complications.	BIO-C REPAIR is a ready-to-usebioceramic reparative material forendodontic complications.	BIO-C SEALER ION+ is a ready-to-use bioceramic root canal sealer,suitable for obturation of root canals.	All materials are ready-to-usepastes. BIO-C REPAIR ION+ andBIO-C REPAIR are intended forendodontic complications such asperforations, while BIO-C SEALERION+ is intended for permanentobturation.
Composition	Calcium and magnesium silicateSilicon oxideZirconium oxideDispersing agentCalcium oxidePotassium sulfateCalcium sulfate	Calcium silicatesSilicon oxideZirconium oxideDispersing agentCalcium oxideIron oxide	Calcium-magnesium silicateSilicon oxideZirconium oxideDispersing agentPotassium sulfateCalcium sulfate	BIO-C REPAIR ION+ and BIO-CSEALER ION+ are mainly composedof calcium-magnesium silicate whileBIO-C REPAIR is composed ofcalcium silicate. They all share thesame dispersing, radiopacifier andrheometry agents.
Principle ofoperation	BIO-C REPAIR ION+ is an insoluble andradiopaque reparative cement whichrequires the presence of moisture toset and harden.Calcium, magnesium and silicon ionsare released in the presence ofmoisture. The calcium sulfate inpresence of moisture produces $SO_4^{2-}$and $Ca^{2+}$ ions. The sulfate anions( $SO_4^{2-}$ ) will combine with $H^+$ from thewater, increasing the concentration of$OH^-$ in the surroundings and the pH ofthe medium.	BIO-C REPAIR is an insoluble andradiopaque reparativecementwhich requires the presence ofmoisture to set and harden.Calcium hydroxide is produced dueto the hydration reaction of thecalcium silicates and calcium oxide,increasing the pH of the medium.	BIO-C SEALER ION+ is an insolubleand radiopaque root canal sealerwhich requires the presence ofmoisture to set and harden.Calcium, magnesium and silicon ionsare released in the presence ofmoisture. The calcium sulfate inpresence of moisture produces $SO_4^{2-}$and $Ca^{2+}$ ions. The sulfate anions( $SO_4^{2-}$ ) will combine with $H^+$ from thewater, increasing the concentrationof $OH^-$ in the surroundings and thepH of the medium.	All materials areinsolubleradiopaque bioceramiccements which require the presence ofmoisture to set and harden.
Indications for use	Furcation or root perforation treatmentvia canal; Furcation or root perforationtreatment via surgical; Internalreabsorption treatment via canal orsurgical; External reabsorptiontreatment; Retrofilling inparendodontic surgery; Direct andindirect pulp capping; Pulpregeneration; Apexification;Apexogenesis and Pulpotomy.	Furcation or root perforationtreatment via canal; Furcation orroot perforation treatment viasurgical; Internal reabsorptiontreatment via canal or surgical;External reabsorption treatment;Retrofilling in parendodonticsurgery; Direct and indirect pulpcapping; Pulp regeneration;Apexification; Apexogenesis andPulpotomy.	Sealing the root canal of permanentteeth;Internal reabsorption treatment.	BIO-C REPAIR ION+ and BIO-CREPAIR share the same indicationsfor use. BIO-C SEALER ION+ isintended mainly for permanentobturation of the root canal.
Delivery form	Single paste	Single paste	Single paste	Equivalent
Design	Ready-to-use syringeBlunt tips	Ready-to-use syringeBlunt tips	Ready-to-use syringeDisposable Intra Canal tips	BIO-C REPAIR ION+ and BIO-CREPAIR are reparative cements withhigher viscosity, therefore, insteadapplying with intracanal tips theyare applied with dental instrumentsthat take the material into the rootcanal chamber directly on thecomplication being treated (e.g.perforation). BIO-C SEALER ION+ isa root canal sealer, its fluidity ishigher, enabling the application ofthe material with intracanal tipsdirectly into the root canal chamberin order to permanent fill the mainand lateral canals.
Nature of contact	Category: External communicatingdeviceContact: Tissue, bone and dentinContact Duration: C - Permanent (>30days)	Category: External communicatingdeviceContact: Tissue, bone and dentinContact Duration: C - Permanent(>30 days)	Category: External communicatingdeviceContact: Tissue, bone and dentinContact Duration: C - Permanent(>30 days)	Equivalent
Sterile	Non-sterile	Non-sterile	Non-sterile	Equivalent
pH	> 10	12,5	10.5	Equivalent
Setting time	90-120 minutes	90-120 minutes	120-240 minutes	BIO-C REPAIR ION+ and BIO-CREPAIR have a shorter setting timecompared to BIO-C SEALER ION+.
Radiopacity	~ 7 mm Al	~ 7 mm Al	≥ 7 mm Al	Equivalent
Biocompatibility	Biocompatible according to ISO10993-1:2009	Biocompatible according to ISO10993-1:2009	Biocompatible according to ISO10993-1:2009	Equivalent

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NON-CLINICAL PERFORMANCE TESTING

BIO-C REPAIR ION+ has undergone extensive bench testing. The following bench tests were performed according to ISO 6876:2012 Dental root canal sealing materials: setting time, solubility and radiopacity. Additional tests are also performed and incorporated into the product acceptance criteria: injectability, X-ray diffraction, particle size distribution and color determination analyses.

Biological evaluation was performed according to ISO 10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process addressing all relevant biological effects. Biocompatibility test results determined that BIO-C REPAIR ION+ is non-sensitizing, non-irritant to oral mucosa of hamsters. Since BIO-C REPAIR ION+ composition is based on principal chemical components in BIO-C REPAIR and BIO-C SEALER ION+, the biocompatibility test data of these devices provide evidence that BIO-C REPAIR ION+ is nonmutagenic, and did not induce genotoxic effects to the bone marrow cells of mice. BIO-C REPAIR ION+ has also met the requirements of absence of acute systemic toxicity after single oral administration and did not demonstrate local and systemic toxic effects when implanted.

CLINICAL PERFORMANCE TESTING

Clinical performance testing was not conducted on the subject device.

CONCLUSION

Based upon a comparison of technology, non-clinical performance testing and similarity in intended use, we concluded that BIO-C REPAIR ION* is substantially equivalent to the predicate devices.

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.