BIOAGGREGATE

K063422 · Innovative Bioceramix, Inc. · KIF · Nov 21, 2006 · Dental

Device Facts

• Record ID: K063422
• Device Name: BIOAGGREGATE
• Applicant: Innovative Bioceramix, Inc.
• Product Code: KIF · Dental
• Decision Date: Nov 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

• Repair of Root Perforations • Repair of Root Resorption • Root End Filling • Apexification • Pulp capping

Device Story

BioAggregate is a hydraulic, ceramic-based powder mixed with a liquid to form a cement for root canal repair. Used by dental professionals in clinical settings to create a hermetic seal within the root canal. The material promotes cementogenesis. It serves as an aluminum-free alternative to traditional mineral trioxide aggregate (MTA) materials, incorporating calcium phosphate to enhance safety and effectiveness. The device is applied directly by the clinician to the site of perforation, resorption, or root end, or used for apexification and pulp capping. It benefits patients by providing a biocompatible, non-cytotoxic, and non-mutagenic material for endodontic repair, ensuring tissue tolerance and effective sealing of the root canal system.

Clinical Evidence

Bench testing only. Tests included working time, setting time, solubility, and radiopacity. Biocompatibility testing confirmed the material is non-mutagenic, non-cytotoxic, lacks allergenic potential, and is well-tolerated by subcutaneous tissues.

Technological Characteristics

Hydraulic cement-like powder composed of biocompatible ceramic particles; aluminum-free; contains calcium phosphate. Physical state: powder-liquid mix. Properties: radiopaque, non-mutagenic, non-cytotoxic. No specific ASTM standards cited.

Indications for Use

Indicated for dental patients requiring root canal repair procedures, including root perforation repair, root resorption repair, 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

• Dentsply International WHITE MTA MATERIAL (K011009)

Reference Devices

• Tantalum Beads - Radiographic Marker (K010348)
• Synthes (USA) chronOS (K041350)
• NovaBone Products, LLC PerioGlas - Bioglass Bone Graft Particulate (K040278)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo and contact information for Innovative BioCeramix Inc. The logo includes the company name in bold, uppercase letters, followed by the letters "IBC" inside of a circle. The address is listed as 3650 Wesbrook Mall, Vancouver, BC V6S 2L2 Canada. The phone number is [phone], and the fax number is [phone].

# 510(k) SUMMARY

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

| SUBMITTER: | Innovative BioCeramix Inc.<br>3650 Wesbrook Mall<br>Vancouver, BC V6S 2L2 Canada<br>Tel: [phone]<br>Fax: [phone] | NOV 2 1 2006 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT: | Dr. Quanzu Yang | |
| SUMMARY PREPARED: | Jul 25, 2006 | |
| TRADE NAME: | BioAggregate | |
| COMMON NAME: | Root Canal Repair Filling Material | |
| CLASSIFICATION NAME: | Root Canal Filling Resin (21 CFR 872.3820, Product Code: KIF) | |
| PREDICATE DEVICE: | Dentsply International WHITE MTA MATERIAL (K011009) | |
| | For specific chemical compositions:<br>• Biomet, Inc. Tantalum Beads - Radiographic Marker (K010348)<br>• Synthes (USA) chronOSTM(K041350)<br>• NovaBone Products, LLC PerioGlas - Bioglass Bone Graft Particulate<br>(K040278) | |
| DEVICE DESCRIPTION: | BioAggregate is a white hydraulic cement-like powder composed of<br>biocompatible ceramic particles. The BioAggregate Powder promotes<br>cementogenesis upon mixing with BioA Liquid and forms a hermetic seal<br>inside the root canal. | |
| INTENDED USE: | • Repair of Root Perforations<br>• Repair of Root Resorption<br>• Root End Filling<br>• Apexification<br>• Pulp capping | |
| TECHNOLOGICAL<br>CHARACTERISTICS: | BioAggregate is equivalent to WHITE MTA MATERIAL,<br>in terms of the physical state (powder-liquid mix), working time, setting<br>time, solubility and radiopacity. Similar major chemical compounds are<br>utilized in the production of both BioAggregate and WHITE MTA<br>MATERIAL. Both materials are non-mutagenic and non-cytotoxic, and are<br>designated for the same indications for use. The primary difference between | |

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Image /page/1/Picture/0 description: The image shows the logo for Innovative BioCeramix Inc. The logo includes the company name in bold, uppercase letters. Below the company name is the address, 3650 Wesbrook Mall.

Vancouver BC Tel. [phone] Fax: [phone]

the two materials is that BioAggregate has an aluminum-free composition, which contains chemical compounds that improve BioAggregate's properties in terms of safety and effectiveness, and includes calcium phosphate.

The additional predicate devices include: Tantalum Beads - Radiographic Marker, Synthes (USA) chronOS™ and PerioGlas - Bioglass Bone Graft Particulate each containing specific chemical compounds that are equivalent to BioAggregate, providing evidence that these chemical compounds are safe and effective for medical devices use.

NON-CLINICAL TESTS BioAggregate has undergone extensive bench and biocompatibility testing PERFORMED: to provide evidences that BioAggregate's physico-chemical properties are substantially equivalent to WHITE MTA MATERIAL. Bench tests included Working Time, Setting Time, Solubility and Radiopacity. Biocompatibility tests results determined that BioAggregate is nonmutagenic, non-cytotoxic, does not cause allergenic potential to tissues after multiple uses and has good tolerance by subcutaneous tissues.

CONCLUSIONS: BioAggregate has the same indications for use, includes similar materials and comparable technological characteristics as WHITE MTA MATERIAL. In addition, the bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. The chemical compounds of BioAggregate that were not equivalent to MTA were found to be safe and effective in Tantalum Beads - Radiographic Marker, Synthes (USA) chronOSTM and PerioGlas - Bioglass Bone Graft Particulate. Therefore, it is concluded that BioAggregate is safe, effective and substantially equivalent to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The eagle is facing to the right. 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

NOV 2 1 2006

Innovative Bioceramix Incorporated C/O Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K063422

Trade/Device Name: BioAggregate Regulation Number: 21 CFR 872.3820 Regulation Name: Regulatory Class: II Product Code: KIF Dated: November 10, 2006 Received: November 13, 2006

Dear Mr. Devine:

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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### Page 2 - Mr. Devine

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Senitte y. Michieu Davis

Chiu Lin, Ph.D. 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

Koballing 510(k) Number (if Known): Device Name: BioAggregate Indications for Use: Repair of Root Perforation . Repair of Root Resorption . Root End Filling . Apexification . Pulp Capping .

ん Prescription Use _ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)

Susan Rump

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3.01-4.10) n of Anesthesiology, General Hospital, con Control, Dental Devices

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