BIO-C SEALER

K172701 · Angelus Industria DE Produtos Odontologicos S/A · KIF · Jan 4, 2018 · Dental

Device Facts

• Record ID: K172701
• Device Name: BIO-C SEALER
• Applicant: Angelus Industria DE Produtos Odontologicos S/A
• Product Code: KIF · Dental
• Decision Date: Jan 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Sealing the root canal of permanent teeth; 2. Internal reabsorption treatment.

Device Story

BIO-C SEALER is a ready-to-use, injectable endodontic bioceramic sealer used for root canal obturation. It is applied by dental professionals in a clinical setting. The device functions as a filling material to seal the root canal system and treat internal reabsorption. It is delivered via an injectable format, simplifying the obturation process for the clinician. By providing a biocompatible seal, it aids in the successful outcome of endodontic procedures and benefits the patient by preventing reinfection and supporting healing of the root canal space.

Clinical Evidence

Bench testing only. Evaluated physical-chemical properties including flow, setting time, film thickness, solubility, and radiopacity, demonstrating comparability to the predicate. Biocompatibility testing confirmed the material is non-mutagenic, lacks allergenic potential, and exhibits good tolerance.

Technological Characteristics

Injectable endodontic bioceramic sealer. Properties include flowability, setting time, film thickness, solubility, and radiopacity. Biocompatible composition.

Indications for Use

Indicated for sealing root canals of permanent teeth and treatment of internal reabsorption in dental patients.

Regulatory Classification

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.

Predicate Devices

• iRoot SP (K080917)
• MTA-FILLAPEX (K140247)
• MTA REPAIR HP (K151047)

Submission Summary (Full Text)

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

January 4, 2018

# Re: K172701

Trade/Device Name: Bio-C Sealer Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: October 12, 2017 Received: October 12, 2017

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. 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mary S. Runner

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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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K172701

Device Name BIO-C SEALER

Indications for Use (Describe)

- Sealing the root canal of permanent teeth; 1.
- 2. Internal reabsorption treatment;

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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# K172701

# 510(k) Summary

## Angelus Indústria de Produtos Odontológicos S/A

## BIO-C SEALER

August 28, 2017

## ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Angelus Indústria de Produtos Odontológicos S/A |
|--------------------|-------------------------------------------------|
| | Rua Waldir Landgraf, 101 |
| | Londrina, PR 86031-218 Brazil |
| | Telephone: [phone] |
| | Fax: [phone] |
| Official Contact: | Juliana Norder |

# International Regulatory Affairs Analyst [e-mail]

## DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | BIO-C SEALER |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Substantial Equivalence: | K080917 iRoot SP (Innovative BioCeramix Inc.) |
| For specific chemical compositions: | k140247 MTA-FILLAPEX (Angelus Indústria de<br>Produtos Odontológicos S/A)<br>k151047 MTA REPAIR HP cleared under (Angelus<br>Indústria de Produtos Odontológicos S/A) |

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#### INTENDED USE

- 1. Sealing the root canal of permanent teeth;
- 2. Internal reabsorption treatment.

#### DEVICE DESCRIPTION

BIO-C SEALER is a ready-to-use injectable endodontic bioceramic sealer, suitable for obturation of root canals.

#### 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 SEALER is substantially equivalent in indications and design principles to the following predicate device:

#### INNOVATIVE BIOCERAMIX INC., iRoot SP cleared under K080917

The subject device and the predicate device have the same intended use and have the 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 the technological characteristics do not raise new issues of safety or effectiveness. Even though BIO-C SEALER's main chemical composition is based on iRoot SP, as mentioned above, the additional chemical components in BIO-C SEALER's composition were found in the following predicate devices:

ANGELUS INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS S/A, MTA-FILLAPEX cleared under K140247 ANGELUS INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS S/A, MTA REPAIR HP cleared under K151047 Therefore, it is concluded that BIO-C SEALER is substantially equivalent to the predicate devices.

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#### PERFORMANCE DATA OR NON-CLINICAL EVIDENCE

BIO-C SEALER has undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to iRoot SP. Bench tests performed are: flow, setting time, film thickness, solubility and radiopacity.

Both devices have comparable flowability, setting time, film thickness, solubility and radiopacity.

The biocompatibility evaluation provide evidence that the product is non-mutagenic, does not cause an allergenic potential after multiple uses and has a good tolerance.

#### CONCLUSION

BIO-C SEALER and its predicate device are designated for equivalent dental applications and have comparable chemical and physical properties and performance specifications. Furthermore, BIO-C SEALER 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.