BOND BONE

K101014 · Mis Implants Technologies , Ltd. · LYC · Oct 21, 2010 · Dental

Device Facts

• Record ID: K101014
• Device Name: BOND BONE
• Applicant: Mis Implants Technologies , Ltd.
• Product Code: LYC · Dental
• Decision Date: Oct 21, 2010
• 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 composed of biphasic calcium sulfate in granulated powder form. Used in oral and maxillofacial surgery to fill, augment, or reconstruct bony defects. Clinician mixes powder with saline to form a paste; material hardens via cementitious reaction in situ. Provided sterile for single-patient use. Acts as a scaffold for bone regeneration or as a resorbable barrier to prevent migration of other graft particles. Benefits patient by facilitating bone repair in periodontal or maxillofacial defects.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through chemical and physical characterization including phase composition, density, porosity, particle size, morphology, setting time, reaction temperature, compressive strength, elastic modulus, pH analysis, and dissolution rate.

Technological Characteristics

Synthetic biphasic calcium sulfate bone graft material. Supplied as granulated powder; forms paste when mixed with saline. Hardens via cementitious reaction. Sterile, single-use. Characteristics include specific density, porosity, particle size, and compressive strength.

Indications for Use

Indicated for use in bone regenerative techniques, either alone or mixed with other bone filling agents to prevent particle migration in osseous defects, or as a resorbable barrier over other bone graft materials 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.

Predicate Devices

• Bond Bone™ (K083858)

Submission Summary (Full Text)

{0}------------------------------------------------

K101014

Implants Technologies Ltd.

### 510(k) Summary:

Bond Bone™

Company Name: MIS Implants Technologies Ltd. P.O.Box 7 Bar Lev Industrial Park 20156, ISRAEL Telephone: [phone] Fax: [phone]

Establishment Registration Number: 3004203816

- Contact Name: Iman Khorshid VP Quality & Regulatory Affairs Telephone: [phone] Fax: [phone] E-mail: [e-mail]
US Agent: Motti Weisman - VP Marketing MIS Implants Technologies Inc. 14-25 Plaza Rd. Suite S-3-5 Fair Lawn New Jersey; 07410 Phone: [phone] [phone] Fax: E-mail: [e-mail]

Date prepared: July 30, 2010

Trade Name: Bond Bone™

Classification name: Bone Grafting Materials

Common/usual name: Bone Grafting Materials, Synthetic

Product Code: LYC

Regulation No.: 872.3930

Class: II

Classification Panel: Dental Products Panel

510 (k) Bond Bone™ Section E - Page 1 of 12

{1}------------------------------------------------

# Implants Technologies Ltd.

#### Predicate Device:

Bond Bone™ from Augma Biomaterials Ltd., Usishkin 8, Netanya 42273, Israel cleared under 510(k) No. K083858.

#### Description of the device:

Bond Bone™ is a synthetic osteoconductive, 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.

#### 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.

#### Substantial Equivalence:

Bond Bone™ has the same intended use as Bond Bone™ from Augma Biomaterials Ltd., Usishkin 8, Netanya 42273, Israel cleared under 510(k) No. K083858, and has same performance characteristics. Bond Bone™ is therefore substantially equivalent to the predicate device.

#### Performance testing:

Bond Bone™ has been tested for a number of chemical and physical characteristics: chemical composition, phase composition, trace of impurities, density and porosity, particle size, morphology, setting time and reaction temperature, compressive strength and elastic modulus, pH analysis and dissolution rate.

All these characteristics are equivalent to those of the predicate device.

510 (k) Bond Bone™ Section E - Page 2 of 13

{2}------------------------------------------------

## Implants Technologies Ltd.

#### Conclusion:

The evaluation of Bond Bone™ does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device.

510 (k) Bond Bone™
Section E – Page 3 of 13

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The overall design is simple and professional.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Iman Khorshid Vice President Quality & Regulatory Affairs MIS Implants Technologies Limited P.O. Box 7 Bar Lev Industrial Park Israel 20156

OCT 2 1 2010

Re: K101014

Trade/Device Name: Bond Bone™ Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: September 7, 2010 Received: September 9, 2010

Dear Ms. Khorshid:

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. 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.

{4}------------------------------------------------

#### Page 2- Ms. Khorshid

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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor Y.ou/Industry/default.htm.

Sincerely vours.

Rh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital, Infection Control and Dental Devices Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized font, with the "I" being taller than the other letters. To the right of the logo is the text "Implants Technologies Ltd." in a smaller font. The text is right-aligned with the "S" in the logo.

OCT 2 1 2010

| 510(k) Number (if known): | K101014 |
|---------------------------|---------|
|---------------------------|---------|

| INDICATIONS FOR USE |
|---------------------|
|---------------------|

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 OR (Part 21 CFR 801 Subpart D)

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)

Susan Runser

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

510(k) Number:

510 (k) UNO Narrow Implant Section D- Page 1 of 1