IROOT BP, MODEL IRBP 4609

K082943 · Innovative Bioceramix, Inc. · KIF · Jan 6, 2009 · Dental

Device Facts

• Record ID: K082943
• Device Name: IROOT BP, MODEL IRBP 4609
• Applicant: Innovative Bioceramix, Inc.
• Product Code: KIF · Dental
• Decision Date: Jan 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Repair of Root Perforation Repair of Root Resorption Root End Filling Apexification Pulp Capping

Device Story

iRoot BP is a ready-to-use, white, hydraulic, premixed injectable calcium silicate paste for permanent root canal repair and filling. It requires water to set and harden; exhibits no shrinkage during setting. Packaged in a preloaded syringe with disposable tips for clinical application by dental professionals. Used for root perforation, root resorption, root end filling, apexification, and pulp capping. Provides radiopaque, insoluble material for endodontic procedures. Benefits include convenient delivery and biocompatible, non-cytotoxic performance.

Clinical Evidence

Bench testing only. Evaluated flow, working time, setting time, dimensional change, solubility, and radiopacity. Biocompatibility testing confirmed non-cytotoxicity, non-mutagenicity, and lack of allergenic potential.

Technological Characteristics

Calcium silicate-based hydraulic paste; radiopaque; aluminum-free. Supplied in preloaded syringe with disposable tips. Sets/hardens in presence of water. No software or electronic components.

Indications for Use

Indicated for dental patients requiring root canal repair and filling, specifically for root perforation, root resorption, root end filling, apexification, and pulp capping.

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

• BioAggregate (K063422)

Reference Devices

• iRoot SP (K080917)
• Jeltrate® Plus™ Impression Material (K952614)
• Clearfil™ Ceramic Primer (K061906)

Submission Summary (Full Text)

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K082943

# 510(k) SUMMARY

## JAN - 6 2009

1628 West 75th Avenue Vancouver, BC V6P 6G2 Canada

> Tel: [phone] Fax: [phone]

INNOVATIVE BIOCERAMIX INC

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] Fax: [phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Quanzu Yang |
| SUMMARY PREPARED: | September 26, 2008 |
| TRADE NAME: | iRoot BP |
| COMMON NAME: | Injectable Root Canal Repair Filling Material |
| CLASSIFICATION NAME: | Resin, Root Canal Filling (21 CFR 872.3820, Product Code: KIF) |
| PREDICATE DEVICES: | <ul><li>BioAggregate (K063422)</li></ul> <b>Specific chemical compositions:</b> <ul><li>BioAggregate (K063422)</li><li>iRoot SP (K080917)</li><li>Jeltrate® Plus™ Impression Material (K952614)</li><li>Clearfil™ Ceramic Primer (K061906)</li></ul> <b>Delivery system:</b> <ul><li>iRoot SP (K080917)</li></ul> |
| DEVICE DESCRIPTION: | iRoot BP Injectable Root Canal Repair Filling Material (iRoot BP) is a convenient ready-to-use white hydraulic premixed injectable BioAggregate paste developed for permanent root canal repair and filling applications. iRoot BP 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 BP does not shrink during setting and demonstrates excellent physical |

### INTENDED USE:

- Repair of Root Perforation �
properties. iRoot BP is packaged in a preloaded syringe and is supplied with

- Repair of Root Resorption .
- Root End Filling
- Apexification

disposable tips.

- Pulp Capping

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K082943

1628 West 75th Avenue
Vancouver, BC
V6P 6G2 Canada
Tel: [phone]
Fax: [phone]

INNOVATIVE BIOCERAMIX INC.

### TECHNOLOGICAL CHARACTERISTICS:

iRoot BP and BioAggregate are designated for the equivalent dental applications, and have comparable chemical and physical properties, and performance specifications.

The main chemical composition of iRoot BP is based on BioAggregate. Additional predicate devices include: iRoot SP, Jeltrate® Plus™ Impression Material and Clearfil™ Ceramic Primer, each contains specific chemical components that are equivalent to those found in iRoot BP; providing evidence that these chemical components are safe and effective for medical device use. Furthermore, iRoot BP and iRoot SP have similar delivery systems.

### NON-CLINICAL TESTS PERFORMED:

CONCLUSIONS:

iRoot BP has undergone extensive bench and biocompatibility testing to provide evidence that iRoot BP's chemical and physical properties are substantially equivalent to BioAggregate and iRoot SP. Bench tests included: flow, working time, setting time, dimensional change following setting, solubility, and radiopacity.

Biocompatibility test results determined that iRoot BP is non-cytotoxic. Since iRoot BP's chemical composition is based on the principal chemical components in both BioAggregate and iRoot SP, the biocompatibility test data of BioAggregate and iRoot SP provides biocompatibility evidence that iRoot BP is non-mutagenic, does not cause an allergenic potential after multiple uses and has a good tolerance by subcutaneous tissue.

iRoot BP has the same indications for use, provides similar chemical, physical and biocompatible properties, and demonstrates comparable performance specifications to BioAggregate. iRoot BP's main chemical composition is based on BioAggregate and the additional chemical components in iRoot BP's composition were found to be safe and effective in iRoot SP, Jeltrate® Plus™ Impression Material and Clearfilm Ceramic Primer. In addition, iRoot BP has a comparable delivery system to iRoot SP. Therefore, it is concluded that iRoot BP is safe, effective and substantially equivalent to the predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three lines extending from the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN - 6 2009

Mr. Quanzu Yang President/ Chief Executive Office Innovative BioCeramix, Incorporated 1628 West 75th Avenue Vancouver, BC V6P 6G2 Canada

Re: K082943

> Trade/Device Name: iRoot BP Injectable Root Canal Repair Filling Material Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: December 12, 2008 Received: December 29, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding posimarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours.

Snyde Y. Michael Duds

Ginette Y. Michaud, MD Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## INDICATIONS FOR USE

82943

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

Device Name:

#### Indications for Use:

.
.

iRoot BP Injectable Root Canal Repair Filling Material

- Repair of Root Perforation
- Repair of Root Resorption
- Root End Filling
- Apexification
- Pulp Capping

l Prescription Use (Part 21 CFR 801 Subpart D)

ੱਕ

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)
S Y Michun Omd

(Division Stan-Uff) Division of Anesthesiology. General Hospital Infection Control. Dental Devices

510(k) Number: K082943

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