ALPHA BIO DENTAL IMPLANT SYSTEM

K063364 · Alpha-Bio Tec , Ltd. · DZE · Mar 14, 2007 · Dental

Device Facts

• Record ID: K063364
• Device Name: ALPHA BIO DENTAL IMPLANT SYSTEM
• Applicant: Alpha-Bio Tec , Ltd.
• Product Code: DZE · Dental
• Decision Date: Mar 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alpha-Bio Dental Implant System® is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Alpha-Bio Dental Implant System® is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Story

Alpha-Bio Tec Dental Implant System comprises endosseous dental implants (one/two-stage, internal/external hex, internal octagonal hex), cover screws, healing caps, abutment systems, and surgical instruments. Implants are surgically placed into the upper or lower jawbone to support prosthetic devices (artificial teeth) to restore chewing function. System supports immediate loading protocols when primary stability is achieved. Used in dental clinics by trained dental professionals. Output is a stable foundation for dental prosthetics, benefiting patients by restoring oral function and aesthetics. Device components are manufactured from titanium alloys and stainless steel.

Clinical Evidence

Bench testing only. Compliance with ISO 7405:1997 (biocompatibility), ASTM F136-02a (titanium alloy), ASTM F1350-02 (stainless steel), and ISO 13402:1995 (surgical instruments). No clinical data provided.

Technological Characteristics

Endosseous root-form dental implants. Materials: Titanium-6Aluminum-4Vanadium ELI (ASTM F136-02a) and 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel (ASTM F1350-02). Features internal/external hex and internal octagonal hex connections. Includes one-piece and two-piece systems. Sterilization via standard methods for dental instruments. No software or energy source.

Indications for Use

Indicated for patients requiring dental prosthetic support in the upper or lower jaw. Specific designs (ATID, DFI, SPI, SFB, ATIE OF, ITO, SPR, ARRP, ARPB, ARRC, ARR, ARB, ARS, ARBS) are indicated for surgical and restorative applications, including immediate loading when primary stability is achieved. 3mm diameter implants are restricted to incisors and cuspids of the maxilla and mandible and denture stabilization. Includes temporary or long-term intra-bony applications for fixation of crowns, bridges, and prostheses, and graft site protection.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• 3i (K022009, K022113)
• Zimmer Tapered screw vent (K013227)
• MIS Implant Technologies Ltd (K040807, K003191)
• Biohorizons (K041938, K032351)
• NobelDirect (K041876)
• IMTEC (K031106, K023067)
• Branemark (K022562)
• Straumann (K033984, K013798)
• SWISSPLUS IMPLANT CORE VENT CORP (K002188)

Submission Summary (Full Text)

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KO63364

: 上一篇:

| <span style="float:left">Alpha-Bio Tec 03/06</span> <span style="float:left">RA Department</span> <span style="float:left">FDA Traditional 510k</span> <span style="float:right">Page 105 of 109</span> | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------|--|
| 510(K) SUMMARY | | | |
| Alpha-Bio Tec® Dental Implant 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: implant, endosseous, root-form | |
| | | Product Code: DZE | |
| | | Regulation No: 872.3640 | |
| | | Class: II | |
| | | Panel: Dental | |
| | | Subsequent Product Code: | |
| | | Name: Abutment, implant, dental, endosseous | |
| | | Product Code: NHA | |

:

Regulation No: 872.3630 Class: II Panel: Dental

···

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Alpha Bio

| Alpha-Bio Tec | 03/06 | RA Department | FDA Traditional 510k | Page 106 of 109 |
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- F. Predicate Devices: The Alpha-Bio Tec® is substantially equivalent to 3i® K022009;K022113; Zimmer Tapered screw vent K013227; MIS Implant Technologies Ltd K040807, K003191 ; Biohorizons K041938; K032351; NobelDirect™ K041876; IMTEC K031106 K023067; Branemark K022562, Straumann K033984; K013798; SWISSPLUS IMPLANT CORE VENT CORP K002188 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.

- G. Device Description: The Alpha-Bio Dental Implant System® consists of one and two stage endosseous form dental implants, internal and external hexagonal; internal octagonal hexagonal; one piece implants system; cover screws and healing caps; abutment systems and superstructures; surgical instruments.
- H. Intended Use / Indication for Use: The Alpha-Bio Dental Implant System® is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Alpha-Bio Dental Implant System® is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
- I. Performance Standards: No performance standards have been established for 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).

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| Alpha-Bio Tec | 03/06 |
|---------------|----------------------|
| RA Department | FDA Traditional 510k |
| Page | 107 of 109 |

- 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 Tec® 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.

Therefore, the Alpha-Bio Tec® Dental Implant System 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 logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

MAR 1 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K063364

Trade/Device Name: Alpha-Bio Tec® Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 9, 2007 Received: March 12, 2007

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 vours.

Chiu-Lin, Ph.D.

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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Amended 3/13/07

Image /page/5/Picture/1 description: The image shows the words "Alpha Bio" in a stylized font. The word "Alpha" is written in a cursive font, while the word "Bio" is written in a more blocky font. The text is black and the background is white. The image appears to be a logo or brand name.

Alpha-Bio Tec 03/06 | RA Department

FDA Traditional 510k Page 109 of 109

## INDICATIONS FOR USE

510(K) Number: K063364

Device Name: Alpha-Bio Tec® Dental Implant System

Indications for Use:

The Alpha-Bio Dental Implant System® is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

Two stage: ATID, DFI, SPI, SFB, ATIE OF, ITO, SPR

One stage: ITO, SPR

One stage and One Piece: ARRP, ARPB, ARRC 3 mm diameter implants are intended only for the incisors and cuspids of the maxilla and mandible they are also Indicated for denture stabilization using multiple implants

One stage and One Piece for temporary or long-term use: ARR, ARB, ARS, ARBS are self tapping titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and long-term fixation of new or existing crown, bridge and prosithesis, and protection of graft sites,

DFI, SPI, ARRP, ARPB and ARRC designs are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

SPI and SFB designs are indicated for immediate loading in single tooth restorations when good primary stability is achieved and with appropriate occlusal loading.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evacuation

Susan Runser

.

206334

Prescription Use
(Per 21 CFR 801.109)

OR

Over the Counter Use