ALPHA BIO BONE FIXATION SCREW SYSTEM

K063769 · Alpha-Bio Tec , Ltd. · DZL · Mar 30, 2007 · Dental

Device Facts

• Record ID: K063769
• Device Name: ALPHA BIO BONE FIXATION SCREW SYSTEM
• Applicant: Alpha-Bio Tec , Ltd.
• Product Code: DZL · Dental
• Decision Date: Mar 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2

Intended Use

The Alpha-Bio Bone Fixation Screw System® is used to stabilize and fixate bone grafts, bone filling materials, and / or barrier membranes used for regeneration of bone in the oral cavity. The system includes titanium screws 1.2mmd and 1.6mmd diameter, and drill instrument for fixating the screw to the bone in the oral cavity at regeneration procedure.

Device Story

System consists of titanium alloy (Gr-5) screws (1.2mm and 1.6mm diameter; 4mm-12mm lengths) and a drill instrument. Used by dental clinicians in the oral cavity to stabilize bone grafts, bone filling materials, or barrier membranes during bone regeneration procedures. The drill prepares the site for screw placement; screws provide mechanical fixation of graft materials/membranes to bone. Benefits include improved stability of regenerative materials, facilitating bone healing. No complex processing or software involved.

Clinical Evidence

Bench testing only. Device compliance demonstrated via recognized standards: ISO 7405 (biocompatibility), ASTM F136 (titanium alloy specs), ASTM F1350 (stainless steel wire specs), ISO 13402 (instrument corrosion/thermal resistance), and UL 544 (medical/dental equipment safety).

Technological Characteristics

Materials: Titanium-6Aluminum-4Vanadium ELI (ASTM F136-02a) and 18 Chromium-14 Nickel-2.5 Molybdenum stainless steel (ASTM F1350-02). Components: 1.2mm and 1.6mm diameter screws (4-12mm length) and drill instrument. Mechanical fixation principle. Sterilization: Not specified, but compliant with ISO 13402 for autoclaving resistance.

Indications for Use

Indicated for stabilization and fixation of bone grafts, bone filling materials, and/or barrier membranes during bone regeneration procedures in the oral cavity.

Regulatory Classification

Identification

An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

Predicate Devices

• Straumann (K050515)
• Straumann (K011698)

Submission Summary (Full Text)

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K06 3769

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| | | Alpha Bio | | MAR 3 0 2007 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|---------------|--------------|
| Alpha-Bio Tec<br>03/06 | RA Department | FDA Traditional 510k | Page 28 of 32 | |
| 510(K) SUMMARY | | | | |
| Alpha-Bio Tec® Bone Fixation Screw System | | | | |
| | 510(k) Number K | | | |
| A. Applicant's Name: | Alpha-Bio Tec Ltd | | | |
| | 7, Embar st. | | | |
| | Industrial Zone Kiryat Arie | | | |
| | POB 3936 ZIP 49130 | | | |
| | Petach-Tikva, Israel | | | |
| | Tel: [phone] | | | |
| | Fax: [phone] | | | |
| | e-mail: [e-mail]; [e-mail] | | | |
| | Web site: www.alpha-bio.net | | | |
| B. Contact Person: | Daniela Ben Shabat | | | |
| | Alpha-Bio Tec Ltd | | | |
| | 7, Embar st. | | | |
| | Industrial Zone Kiryat Arie | | | |
| | POB 3936 ZIP 49130 | | | |
| | Petach-Tikva, Israel | | | |
| | Tel: [phone] | | | |
| | Fax: [phone] | | | |
| | e-mail: [e-mail] | | | |
| | Web site: www.alpha-bio.net | | | |
| C. Date Prepared: | March 2006 | | | |
| D. Trade Name: | Alpha-Bio Tec® | | | |
| E. Classification: | Name: | Screw, Fixation, Intraosseous | | |
| | Product Code: | DZL | | |
| | Regulation No: | 872.4880 | | |
| | Class: | II | | |
| | Panel: | Dental | | |
| F. Predicate Devices: | The Alpha-Bio Bone Fixation Screw System is substantially equivalent to Straumann K050515; K011698; in terms of intended use, indications for use, technological characteristics, performance and user interface. | | | |
| | The predicate device is Class II medical devices. | | | |
| | A discussion of substantial equivalence is provided in Section 3 of this submission. | | | |

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Alpha Bio

| Alpha-Bio Tec 03/06 | RA Department | FDA Traditional 510k | Page 29 of 32 |
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בס"ד

- G. Device Description: The Alpha-Bio Bone Fixation Screw System consists of titanium alloy Gr-5 screws with 1.2mmd and 1.6mmd diameter, and with 4mm-12mm lengths. This system includes drill instrument for fixating the screw to the bone in the oral cavity at regeneration procedure
- H. Intended Use / Indication for Use: The Alpha-Bio Bone Fixation Screw System is indicated for stabilize and fixate bone grafts, bone filling materials, and / or barrier membranes used for regeneration of bone in the oral cavity. The system includes titanium screws 1.2mmd and 1.6mmd diameter, and drill instrument for fixating the screw to the bone in the oral cavity at regeneration procedure.
- Performance Standards: No performance standards have been established for I. such devices under Section 514 of the Federal Food, Drug, and Cosmetic Act.

The device complies with the following recognized standards:

- ISO 7405:1997, Dentistry Preclinical Evaluation of . Biocompatibility of Medical Devices Used in Dentistry - Test Methods for Dental
- F136-02a: 2004 Standard Specification for Wrought . Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
- ASTM F1350-02, 2002 Standard Specification for . Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673).
- . ISO 13402:1995. Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure.
- UL 544 (1998):, Standard for Medical and Dental . Equipment - Ed. 4.0.
- J. Substantial Equivalence: There are no unique applications, indications, materials or specifications presented below. Evidence of equivalence has been demonstrated through:
- . The Alpha-Bio Tect intended use and indications for use were previously cleared by FDA for the predicate device.
- · The technical characteristics of the Alpha-Bio Tec® are similar to those of the predicate device.
- · Safety and performance testing.

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| Alpha-Bio Tec 03/06 | RA Department | FDA Traditional 510k | Page 30 of 32 | רס"ד |
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Therefore, the Alpha-Bio Tec® is substantially equivalent to its predicate devices as cited above and raises no new safety and/or effectiveness issues.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alpha-Bio Tec Limited C/O Mr. Daniel J. Manelli Attorney Manelli & Fisher, P.L.L.C. 5335 Wisconsin Avenue, NW Suite 440 Washington, DC 20015

MAR 3 0 2007

Re: K063769 Trade/Device Name: Alpha Bio Tec® Bone Fixation Screw System Regulation Number: 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: December 19, 2006 Received: December 20, 2006

Dear Mr. Manelli:

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. Manelli

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,

Sydtte y. Michael md.

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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| Alpha-Bio Tec<br>03/06 | RA Department |
|------------------------|---------------|
| FDA Traditional 510k | Page 32 of 32 |

## INDICATIONS FOR USE

510(k) Number (if known): KO (03769

Device Name: Alpha Bio Tec® Bone Fixation Screw System

Indications for Use:

The Alpha-Bio Bone Fixation Screw System® is used to stabilize and fixate bone grafts, bone filling materials, and / or barrier membranes used for regeneration of bone in the oral cavity. The system includes titanium screws 1.2mmd and 1.6mmd diameter, and drill instrument for fixating the screw to the bone in the oral cavity at regeneration procedure.

Prescription Use V (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Dentrol, Dental Devices ു (k) Number: