Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and biological evaluation of a bioceramic reparative material, with no mention of AI or ML.

Therapeutic

Yes
The device is a bioceramic reparative material used for various dental treatments like furcation or root perforation, reabsorption, pulp capping, and apexification, which are all therapeutic interventions.

Diagnostic

No

Explanation: The device, BIO-C REPAIR ION+, is a bioceramic reparative material intended for the treatment and repair of various dental conditions. Its function is to treat and repair, not to identify or diagnose diseases or conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "bioceramic reparative material" provided as a "single paste in a syringe," indicating it is a physical substance and delivery mechanism, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended uses listed are all related to treating conditions within the human body, specifically in the root canal system and surrounding tissues. This involves direct application of the material to the patient.
Device Description: The description clearly states it's a "bioceramic reparative material ready-to-use suitable for furcation or root perforation treatment via canal, etc." It's a material applied to the patient.
Lack of In Vitro Activities: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) outside of the body to provide information about a physiological state, health, or disease.

IVDs are devices used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a therapeutic material applied directly to the patient for repair and treatment.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

· 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.

Product codes (comma separated list FDA assigned to the subject device)

KIF

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K180185 BIO-C REPAIR (Angelus Indústria de Produtos Odontológicos S/A)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K190537 BIO-C SEALER ION+ (Angelus Indústria de Produtos Odontológicos S/A)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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/A
Rua Waldir Landgraf, 101
Londrina, PR 86031-218 Brazil
Telephone: +55 (43) 2101-3200
Fax: +55 (43) 2101-3201
Official Contact:	Juliana Norder Trostdorf
Regulatory Affairs Coordinator
juliana.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 de
Produtos Odontológicos S/A)
Reference Device:	K190537 BIO-C SEALER ION+ (Angelus Indústria de
Produtos Odontológicos S/A)

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DEVICE DESCRIPTION

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.

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 the
Differences |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | BIO-C REPAIR ION+ | BIO-C REPAIR | BIO-C SEALER ION+ | |
| Manufacturer | ANGELUS INDÚSTRIA DE PRODUTOS
ODONTOLÓGICOS S/A | ANGELUS INDÚSTRIA DE
PRODUTOS ODONTOLÓGICOS
S/A | ANGELUS INDÚSTRIA DE
PRODUTOS ODONTOLÓGICOS S/A | - |
| Device Description | BIO-C REPAIR ION+ is a ready-to-use
bioceramic reparative material for
endodontic complications. | BIO-C REPAIR is a ready-to-use
bioceramic reparative material for
endodontic 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-use
pastes. BIO-C REPAIR ION+ and
BIO-C REPAIR are intended for
endodontic complications such as
perforations, while BIO-C SEALER
ION+ is intended for permanent
obturation. |
| Composition | Calcium and magnesium silicate
Silicon oxide
Zirconium oxide
Dispersing agent
Calcium oxide
Potassium sulfate
Calcium sulfate | Calcium silicates
Silicon oxide
Zirconium oxide
Dispersing agent
Calcium oxide
Iron oxide | Calcium-magnesium silicate
Silicon oxide
Zirconium oxide
Dispersing agent
Potassium sulfate
Calcium sulfate | BIO-C REPAIR ION+ and BIO-C
SEALER ION+ are mainly composed
of calcium-magnesium silicate while
BIO-C REPAIR is composed of
calcium silicate. They all share the
same dispersing, radiopacifier and
rheometry agents. |
| Principle of
operation | BIO-C REPAIR ION+ is an insoluble and
radiopaque reparative cement which
requires the presence of moisture to
set and harden.
Calcium, magnesium and silicon ions
are released in the presence of
moisture. The calcium sulfate in
presence of moisture produces $SO_4^{2-}$
and $Ca^{2+}$ ions. The sulfate anions
( $SO_4^{2-}$ ) will combine with $H^+$ from the
water, increasing the concentration of
$OH^-$ in the surroundings and the pH of
the medium. | BIO-C REPAIR is an insoluble and
radiopaque reparative
cement
which requires the presence of
moisture to set and harden.
Calcium hydroxide is produced due
to the hydration reaction of the
calcium silicates and calcium oxide,
increasing the pH of the medium. | BIO-C SEALER ION+ is an insoluble
and radiopaque root canal sealer
which requires the presence of
moisture to set and harden.
Calcium, magnesium and silicon ions
are released in the presence of
moisture. The calcium sulfate in
presence of moisture produces $SO_4^{2-}$
and $Ca^{2+}$ ions. The sulfate anions
( $SO_4^{2-}$ ) will combine with $H^+$ from the
water, increasing the concentration
of $OH^-$ in the surroundings and the
pH of the medium. | All materials are
insoluble
radiopaque bioceramic
cements which require the presence of
moisture to set and harden. |
| Indications for use | 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; Pulp
regeneration; Apexification;
Apexogenesis and Pulpotomy. | 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; Pulp regeneration;
Apexification; Apexogenesis and
Pulpotomy. | Sealing the root canal of permanent
teeth;
Internal reabsorption treatment. | BIO-C REPAIR ION+ and BIO-C
REPAIR share the same indications
for use. BIO-C SEALER ION+ is
intended mainly for permanent
obturation of the root canal. |
| Delivery form | Single paste | Single paste | Single paste | Equivalent |
| Design | Ready-to-use syringe
Blunt tips | Ready-to-use syringe
Blunt tips | Ready-to-use syringe
Disposable Intra Canal tips | BIO-C REPAIR ION+ and BIO-C
REPAIR are reparative cements with
higher viscosity, therefore, instead
applying with intracanal tips they
are applied with dental instruments
that take the material into the root
canal chamber directly on the
complication being treated (e.g.
perforation). BIO-C SEALER ION+ is
a root canal sealer, its fluidity is
higher, enabling the application of
the material with intracanal tips
directly into the root canal chamber
in order to permanent fill the main
and lateral canals. |
| Nature of contact | Category: External communicating
device
Contact: Tissue, bone and dentin
Contact Duration: C - Permanent (>30
days) | Category: External communicating
device
Contact: Tissue, bone and dentin
Contact Duration: C - Permanent
(>30 days) | Category: External communicating
device
Contact: Tissue, bone and dentin
Contact 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-C
REPAIR have a shorter setting time
compared to BIO-C SEALER ION+. |
| Radiopacity | ~ 7 mm Al | ~ 7 mm Al | ≥ 7 mm Al | Equivalent |
| Biocompatibility | Biocompatible according to ISO
10993-1:2009 | Biocompatible according to ISO
10993-1:2009 | Biocompatible according to ISO
10993-1:2009 | 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.