IROOT FM

K130312 · Innovative Bioceramix, Inc. · KIF · Sep 18, 2014 · Dental

Device Facts

• Record ID: K130312
• Device Name: IROOT FM
• Applicant: Innovative Bioceramix, Inc.
• Product Code: KIF · Dental
• Decision Date: Sep 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in the treatment of root canals, or following pulpectomy, or for the apexogenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha. These indications include application in: Apexification Periapical Lesions Root Resorption Temporary Root Filling Perforations Underdeveloped pulpless teeth

Device Story

iRoot FM is a premixed, ready-to-use, injectable, radiopaque, white hydraulic bioceramic paste; used for root canal filling. Supplied in pre-loaded syringes with disposable tips. Material is aluminum-free, calcium silicate-based; requires water to set. Used by dental professionals in clinical settings for endodontic procedures. Acts as a filling material to seal prepared root canals; supports apexification and treatment of perforations or root resorption. Benefits include ease of application and biocompatibility.

Clinical Evidence

Bench testing only. Non-clinical testing included flow, working time, setting time, and radiopacity. Biocompatibility testing confirmed the material is non-cytotoxic, non-mutagenic, and lacks allergenic potential.

Technological Characteristics

Aluminum-free, calcium silicate-based hydraulic bioceramic paste. Requires water for setting. Supplied as a premixed, injectable paste in a pre-loaded syringe with disposable tips. Radiopaque.

Indications for Use

Indicated for patients requiring root canal treatment, pulpectomy, apexogenesis, apexification, or tip filling of prepared root canals. Includes applications for apexification, periapical lesions, root resorption, temporary root filling, perforations, and underdeveloped pulpless teeth.

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)
• iRoot FS (K063422)
• BioAggregate (K033585)
• Diapex

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 18, 2014

Innovative BioCeramix, Inc. Quanzu Yang President/CEO 1628 West 75th Avenue Vancouver, BC V6P 6G2 CANADA

Re: K130312

Trade/Device Name: iRoot FM Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Codes: KIF Dated: June 26, 2014 Received: June 30, 2014

Dear Mr. Yang:

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.

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Page 2 - Mr. Yang

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. 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 STATEMENT 6.0

The following document is included in this section:

- INDICATIONS FOR USE STATEMENT ●

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## INDICATIONS FOR USE

## 510(k) Number (if Known): K130312

Device Name: iRoot FM Injectable Root Canal Filling Material

## Indications for Use:

For use in the treatment of root canals, or following pulpectomy, or for the apexogenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.

These indications include application in:

- Apexification
- Periapical Lesions
- Root Resorption ●
- Temporary Root Filling ●
- Perforations ●
- Underdeveloped pulpless teeth ●

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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#### 7.0 510(k) SUMMARY

The following document is included in this section:

- 510(k) SUMMARY .

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Image /page/5/Picture/0 description: The image shows the logo and contact information for Innovative BioCeramix Inc. The logo includes the company name in blue text and the letters "IBC" in a green circle. The contact information includes the company's address, phone number (604-221-6800), and fax number (604-677-6129).

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# 510(k) SUMMARY

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92

| SUBMITTER: | Innovative BioCeramix Inc.<br>1628 West 75th Avenue<br>Vancouver, BC<br>V6P 6G2 Canada<br>Tel: [phone]<br>Fax: [phone] |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Quanzu Yang |
| SUMMARY<br>PREPARED: | June 4, 2014 |
| TRADE NAME: | iRoot FM |
| COMMON NAME: | Injectable Root Canal Filling Material |
| CLASSIFICATION<br>NAME: | Resin, Root Canal Filling (21 CFR 872.3820, Product Code: KIF) |
| PREDICATE DEVICES: | iRoot SP<br>(K080917)<br>(K063422)<br>BioAggregate<br>●<br>(K033585)<br>Diapex<br>● |
| DEVICE<br>DESCRIPTION: | iRoot FM Injectable Root Canal Filling Material (iRoot FM) is a<br>convenient premixed ready-to-use injectable, radiopaque, white<br>hydraulic bioceramic paste developed for root canal filling |

supplied with disposable tips.

to set.

applications. iRoot FM is an aluminum-free material based on a calcium silicate composition, which requires the presence of water

iRoot FM is packaged in a pre-loaded syringe and is

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Image /page/6/Picture/0 description: The image shows the logo and contact information for Innovative BioCeramix Inc. The logo includes the company name in blue text, followed by the letters "IBC" in a green circle. The contact information includes the company's address, phone number (604-221-6800), and fax number (604-677-6129).

### INTENDED USE:

For use in the treatment of root canals, or following pulpectomy, or for the apexogenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with guttapercha.

These indications include application in:

- Apexification
- Periapical Lesions
- Root Resorption
- . Temporary Root Filling
- Perforations ●
- . Underdeveloped pulpless teeth

## TECHNOLOGICAL CHARACTERISTICS:

The main chemical composition and performance specifications of iRoot FM is based on iRoot SP. Additional predicate devices iRoot FS and Diapex, each contains specific chemical include: components that are equivalent to those found in iRoot FM; providing evidence that these chemical components are utilized for medical device use.

iRoot FM and Diapex are designated for the equivalent dental applications. In addition, iRoot FM has a comparable delivery system and similar labeling to iRoot SP and Diapex.

iRoot FM has undergone extensive bench and biocompatibility NON-CLINICAL TESTS testing to provide evidence that iRoot FM's chemical and physical PERFORMED: properties are substantially equivalent to iRoot SP. Bench tests included: flow, working time, setting time and radiopacity.

> Biocompatibility test results determined that iRoot FM is noncytotoxic. Since iRoot FM's chemical composition is based on the principal chemical components in iRoot SP, iRoot FS and BioAggregate, the biocompatibility test data of these devices provides biocompatibility evidence that iRoot FM is nonmutagenic, does not cause an allergenic potential after multiple uses and has a good tolerance by subcutaneous tissue.

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Image /page/7/Picture/0 description: The image shows the logo and contact information for Innovative BioCeramix Inc. The logo includes the company name in blue text and the letters "IBC" in a green circle. The contact information includes the company's address at 1628 West 75th Avenue, Vancouver, BC, V6P 6G2 Canada, as well as their phone number (604-221-6800) and fax number (604-677-6129).

## CONCLUSIONS:

demonstrates chemical, physical, iRoot FM performance specifications and biocompatible properties to iRoot SP. iRoot FM's main chemical composition is based on iRoot SP. In addition, BioAggregate provides biocompatibility verification for iRoot FM. iRoot FM and Diapex have equivalent indications for use. Furthermore, iRoot FM has a comparable delivery system and similar labeling to iRoot SP and Diapex. Therefore, it is concluded that iRoot FM is substantially equivalent in safety and effectiveness to the predicate devices.