IROOT BP PLUS

K092715 · Innovative Bioceramix, Inc. · KIF · Sep 28, 2009 · Dental

Device Facts

• Record ID: K092715
• Device Name: IROOT BP PLUS
• Applicant: Innovative Bioceramix, Inc.
• Product Code: KIF · Dental
• Decision Date: Sep 28, 2009
• Decision: SESE
• Submission Type: Special
• 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 Plus is a ready-to-use, white, hydraulic, premixed bioceramic paste for permanent root canal repair and surgical applications. Composed of calcium silicate, the material is insoluble, radiopaque, and aluminum-free; it sets and hardens in the presence of water without shrinking. The device is supplied in preloaded containers (jars and unit dose cups). It is used by dental professionals in a clinical setting to fill or repair root structures. The material provides a stable, biocompatible seal for endodontic procedures, facilitating healing in cases of perforation, resorption, or pulp exposure.

Clinical Evidence

No clinical data. Bench and shelf-life testing performed to verify chemical and physical properties against the predicate device.

Technological Characteristics

Bioceramic paste based on calcium silicate composition. Requires water for setting/hardening. Radiopaque, aluminum-free. Packaged in jars and unit dose cups. Delivery system comparable to Cavit-W. Non-mechanical, chemical-setting material.

Indications for Use

Indicated for dental patients requiring root canal repair or surgical applications, 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

• iRoot BP (K082943)
• BioAggregate (K063422)
• Cavit-W (K875133)
• VitalCare I.V. Adminstration Set (K050906)

Submission Summary (Full Text)

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K092715

... ..........................................................................................................................................................................

INNOVATIVE BIOCERAMIX INC.

SEP 2 9 2009

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

::

Tel: [phone] Fax: [phone]

# 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] Fax: [phone] |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Quanzu Yang |
| SUMMARY<br>PREPARED: | August 21, 2009 |
| TRADE NAME: | iRoot BP Plus |
| COMMON NAME: | Root Repair Material |
| CLASSIFICATION<br>NAME: | Resin, Root Canal Filling (21 CFR 872.3820, Product Code: KIF) |
| PREDICATE DEVICES: | <ul><li>iRoot BP (K082943)</li><li>BioAggregate (K063422)</li><li>Cavit-W (K875133)</li><li>VitalCare I.V. Adminstration Set (K050906)</li></ul> |
| DEVICE<br>DESCRIPTION: | iRoot BP Plus Root Repair Material (iRoot BP Plus) is a convenient ready-to- use white hydraulic premixed bioceramic paste developed for permanent root canal repair and surgical applications. iRoot BP 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 BP does not shrink during setting and demonstrates excellent physical properties. iRoot BP Plus is packaged in a preloaded container. |
| INTENDED USE: | <ul><li>Repair of Root Perforation</li></ul> |

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

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Image /page/1/Picture/0 description: The image shows the logo and contact information for Innovative BioCeramix Inc. The address is listed as 1628 West 75th Avenue, Vancouver, BC V6P 6G2 Canada. The telephone number is 604-221-6800 and the fax number is 604-677-6129.

### TECHNOLOGICAL CHARACTERISTICS:

iRoot BP Plus and iRoot BP are designated for the equivalent dental applications, and have comparable chemical and physical properties, and iRoot BP Plus is a modification of iRoot BP. performance specifications. The packaging for iRoot BP Plus includes jars and unit dose cups.

Additional predicate devices include: BioAggregate, Cavit-W and VitalCare I.V. Administration Set, each contains specific material components that are equivalent to those found in the packaging for iRoot BP Plus; providing evidence that these materials are safe and effective for medical device use. Furthermore, iRoot BP Plus and Cavit-W have similar delivery systems.

#### NON-CLINICAL TESTS PERFORMED:

iRoot BP Plus has undergone bench and shelf life testing, which provides evidence that iRoot BP's chemical and physical properties are substantially equivalent to iRoot BP.

#### CONCLUSIONS:

iRoot BP Plus has the equivalent indications for use, comparable chemical composition, physical properties and performance specifications to iRoot BP. The additional material components found in iRoot BP Plus's packaging were found to be safe and effective in BioAggregate, Cavit-W and VitalCare I.V. Administration Set. In addition, iRoot BP Plus has a comparable delivery system to Cavit-W. Therefore, it is concluded that iRoot BP Plus is safe, effective and substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus. The logo is black and white.

Image /page/2/Picture/2 description: The image shows the date "SEP 29 2009" in a bold, sans-serif font. The letters and numbers are clearly printed, with a slight blurriness around the edges. The date is likely part of a document or label.

Food and Drug Administration 10903 New Hampshire Avenne Document Mail Center - WO66-G609 Silver Spring, MD 20993-00007

Mr. Quanzu Yang President/Chief Executive Officer Innovative BioCeramix Incorporated 1628 West 75th Avenue Vancuver, BC V6P 6G2 CANADA

Re: K092715

Trade/Device Name: iRoot BP Plus Root Repair Material Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: August 21, 2009 Received: September 3, 2009

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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In 1 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

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Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if Known):

09 2715

Device Name:

iRoot BP Plus Root Repair Material

Indications for Use:

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

ー 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)

Kai Mclay for WSP

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K092715

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