iRoot SP Plus

K231259 · Innovative Bioceramix, Inc. · KIF · May 31, 2023 · Dental

Device Facts

• Record ID: K231259
• Device Name: iRoot SP Plus
• Applicant: Innovative Bioceramix, Inc.
• Product Code: KIF · Dental
• Decision Date: May 31, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Permanent obturation of the root canal following vital pulp-extirpation. Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.

Device Story

iRoot SP Plus is a premixed, ready-to-use, injectable white hydraulic cement paste for permanent root canal filling and sealing. Composed of calcium silicate, the material is insoluble, radiopaque, and aluminum-free; it requires water to set and harden. The device is supplied in a pre-loaded syringe with disposable tips for clinical use by dental professionals. It functions as a root canal sealer to fill and seal the canal space after pulp removal. The addition of 3-(Trimethoxysilyl)propyl methacrylate acts as a coupling agent, and barium silicate enhances radiopacity. The device provides a stable, biocompatible seal for the root canal system, facilitating successful endodontic treatment.

Clinical Evidence

No clinical tests were performed for this submission. Safety and effectiveness are supported by the predicate device (iRoot SP), which has been marketed since 2008 with over a million global sales and clinical studies spanning up to four years. Non-clinical bench testing was conducted according to ISO 6876 (Third edition 2012-06-01) to compare iRoot SP Plus with iRoot SP.

Technological Characteristics

Calcium silicate-based hydraulic cement paste; insoluble, radiopaque, aluminum-free. Includes 3-(Trimethoxysilyl)propyl methacrylate (coupling agent) and barium silicate (radiopacifier). Supplied in pre-loaded syringe with disposable tips. Sets/hardens in the presence of water. Bench testing performed per ISO 6876:2012.

Indications for Use

Indicated for permanent root canal obturation following vital pulp-extirpation or removal of infected/necrotic pulp and placement of intracanal dressings.

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)

Reference Devices

• iRoot BP (K082943)
• Metapaste Calcium Hydroxide With Barium Sulfate Temporary Root Canal Filling (K032605)
• ProFil Composites (K103190)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

May 31, 2023

Innovative BioCeramix, Inc. Quanzu Yang CEO 8218 North Fraser Way Rm 101 Burnaby, BC V3N0E9 CANADA

Re: K231259

Trade/Device Name: iRoot SP Plus Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: April 18, 2023 Received: May 1, 2023

#### Dear Quanzu 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. 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.

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

Sincerely.

# Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K231259

Device Name

iRoot SP Plus

Indications for Use (Describe)

· Permanent obturation of the root canal following vital pulp-extirpation

| • Permanent obturation of the root canal following removal of infected or necrotic pulp and |
|---------------------------------------------------------------------------------------------|
| placement of intracanal dressings. |

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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Image /page/3/Picture/0 description: The image shows the logo for Innovative BioCeramix Inc. The logo consists of the letters "IBC" in a stylized font, followed by the words "Innovative BioCeramix Inc." in a serif font. The letters "IBC" are in a teal color, while the rest of the text is in black. The logo is simple and professional, and it conveys the company's focus on innovation and bioceramics.

# 510(k) SUMMARY - K231259

## Contact Details

Applicant Name: Innovative BioCeramix Inc. Applicant Address: 8218 North Fraser Way RM 101 Burnaby BC V3N0E9 Canada Applicant Contact Telephone: [phone] Applicant Contact: Dr. Quanzu Yang Applicant Contact Email: [e-mail]

#### Device Name

Device Trade Name: iRoot SP Plus Common Name: Root canal filling resin Classification Name: Resin. Root Canal Filling Regulation Number: 872.3820 Product Code: KIF 510(k) Number: K231259

#### Legally Marketed Predicate Device

| Predicate # | Predicate Trade name | Product<br>Code |
|-------------|----------------------|-----------------|
| K080917 | iRoot SP | KIF |

#### Legally Marketed Reference Devices

| Reference # | Reference Trade name | Product Code |
|-------------|---------------------------------------------------------------------------------|--------------|
| K082943 | iRoot BP | KIF |
| K032605 | Metapaste Calcium Hydroxide With Barium Sulfate Temporary<br>Root Canal Filling | KIF |
| K103190 | ProFil Composites | EBF |

#### Device Description Summary

iRoot SP Plus Root Canal Sealer (iRoot SP Plus) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. iRoot SP Plus is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot SP Plus demonstrates substantially equivalent physical properties to iRoot SP. iRoot SP Plus is packaged in a pre-loaded syringe and is supplied with disposable Tips.

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#### Indications For Use

- Permanent obturation of the root canal following vital pulp-extirpation
- · Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.

## Indications For Use Comparison

The indications for use of iRoot SP Plus are equivalent to its primary predicate device of iRoot SP

## Technological Comparison

iRoot SP Plus modifies iRoot SP by adding two additional materials to the primary predicate device. One of which is 3-(Trimethoxysilyl)propyl methacrylate, used as a coupling agent, for which we draw substantial equivalence with the reference device iRoot BP. The other being Barium silicate which will increase the radiopacity of the device, for which we draw substantial equivalence with the Barium Silicate found in the reference device ProFil and the Barium sulfate found in the reference device Metapaste.

## Non-Clinical and/or Clinical Tests Summary & Conclusions

No Clinical tests were done specifically for this submission however, the predicate device iRoot SP has safetly been on the market since 2008 with over a million of global sales. iRoot SP also has clinical studies that have spanned up to four years in time over hundreds of clinical cases, which concluded that iRoot SP is safe and effective for use on patients. The non-clinical tests, based on ISO 6876 Third edition 2012-06-01, performed on both iRoot SP and iRoot SP Plus have shown that iRoot SP Plus is substantially equivalent to iRoot SP. Based on the evidence provided by the clinical and non-clinical tests we can say that iRoot SP Plus is safe and effective.