BOND BONE

K083858 · Augma Biomaterials, Ltd. · LYC · Mar 17, 2009 · Dental

Device Facts

• Record ID: K083858
• Device Name: BOND BONE
• Applicant: Augma Biomaterials, Ltd.
• Product Code: LYC · Dental
• Decision Date: Mar 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bond Bone™ is indicated for use in the following ways: by itself in bone regenerative techniques, mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and to provide a resorbable barrier over other bone graft material.

Device Story

Bond Bone™ is a synthetic, osteoconductive, bioresorbable bone grafting material; supplied as granulated powder composed of biphasic calcium sulfate. Clinician mixes powder with saline to form a paste; paste hardens in situ via cementitious reaction. Used in oral and maxillofacial surgery to fill, augment, or reconstruct bony defects; functions as standalone graft, particle migration preventer when mixed with other agents, or resorbable barrier over other grafts. Sterile, single-patient use device.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Synthetic biphasic calcium sulfate; granulated powder form; hardens via cementitious reaction with saline; osteoconductive; bioresorbable; sterile; single-patient use.

Indications for Use

Indicated for use in patients requiring bone regeneration, augmentation, or reconstruction of periodontal or bony defects in the oral and maxillofacial region.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Submission Summary (Full Text)

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K683858

# 510(k) Summary

# Augma Biomaterials, Ltd. Bond Bone™

## ADMINISTRATIVE INFORMATION

Manufacturer Name:

Augma Biomaterials, Ltd. 8 Usishkin Street Netanya 42273 Israel Telephone: [phone] Fax: [phone]

Official Contact:

Representative/Consultant:

Dr. Amos Yahav

David J. Collette or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: [phone] Fax: [phone] email: [e-mail] [e-mail]

### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations: Product Code Classification Panel: Reviewing Branch:

Bond Bone™ Bone Grafting Material, Synthetic 21 CFR 872.3930 LYC Dental Products Panel Dental Devices Branch

#### INTENDED USE

Bond Bone™ is indicated for use in the following ways: by itself in bone regenerative techniques, mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and to provide a resorbable barrier over other bone graft material.

MAR 1 7 2009

Bond Bone™

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510(k) Summary

K083958

Bond Bone

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## DEVICE DESCRIPTION

Bond Bone™ is a synthetic ostcoconductive, bioresorbable bone grafting material composed of biphasic calcium sulfate in granulated powder form, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. When mixed with saline, Bond Bone forms a paste and hardens via a cementitious reaction. The product is provided sterile and for single patient use.

## EQUIVALENCE TO MARKETED PRODUCT

Augma Biomaterials, Ltd., demonstrated that, for the purposes of FDA's regulation of medical devices, Bond Bone is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

APR - 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Augma Biomaterials, Limited C/o Mr. David J. Collette PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K083858

Trade/Device Name: Bond Bone™ Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: December 23, 2008 Received: December 29, 2008

Dear Mr. Collette:

This letter corrects our substantially equivalent letter of March 12, 2009.

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 (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 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 continue 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/dsma/dsmamain.html

Sincerely yours,

*Susan Runre*

Ginette Y. Michaud, M.D. 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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510(k) Premarket Notification

K083858

Bond Bone™

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## Indications for Use

510(k) Number (if known):

Bond Bone™ Device Name:

Indications for Use:

Bond Bone™ is indicated for use in the following ways: by itself in bone regenerative techniques, mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and to provide a resorbable barrier over other bone graft material.

| Prescription Use | X |
|-----------------------------|---|
| (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)

| (Division Sigi. Off) | |
|----------------------------------------------|--|
| Division of An sthesiology, General Hospital | |
| Infection Contiui, Dental Devices | |

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