LEONE IMPLANT SYSTEM

K050586 · Leone S.P.A. · DZE · Feb 27, 2006 · Dental

Device Facts

• Record ID: K050586
• Device Name: LEONE IMPLANT SYSTEM
• Applicant: Leone S.P.A.
• Product Code: DZE · Dental
• Decision Date: Feb 27, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Leone Implant System is indicated for single or multiple tooth replacement, or for use in terminal or intermediate edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches. The system is designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth. It can work as an abutment system for partial/total prosthetic restorations or as an anchorage system for removable prosthodontics.

Device Story

The Leone Implant System consists of a titanium fixture and abutment; components are joined via a self-locking tapered connection utilizing a Morse cone and hexagon. The device is surgically inserted into the mandibular or maxillary bone structure to replace missing teeth. It serves as an abutment for fixed bridges, partial dentures, or as an anchorage for removable prosthodontics. The system is used by dental professionals in a clinical setting to restore oral function and aesthetics for patients with tooth loss.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons.

Technological Characteristics

Titanium construction; self-locking tapered connection (Morse cone and hexagon); endosseous dental implant; intended for surgical insertion into bone.

Indications for Use

Indicated for single or multiple tooth replacement in edentulous sites of the mandible or maxilla, including totally edentulous arches, for patients requiring prosthetic restoration or removable prosthodontics.

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

• Bicon Dental Implant System (K994037)
• ITI Dental Implant System (K031055)

Submission Summary (Full Text)

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FEB 2 7 2006

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### SUMMARY

Submitter's name: Address:

Leone S.p.A. 50, Via P. A Quaracchi Sesto, Fiorentino, Italy I-50019

Phone: Fax number: +39.055.30441 +39.055.374808

Name of contact person:

Greg Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone]

Date the summary was prepared: March 3, 2005

| Name of the device: | Leone Implant System |
|----------------------------|----------------------|
| Trade or proprietary name: | Dental Implant |
| Common or usual name: | Dental Implant |
| Classification name: | Dental Implant |

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:

| Reference # | Device Name | Manufacturer |
|-------------|-----------------------------|---------------|
| K994037 | Bicon Dental Implant System | Bicon, Inc |
| K031055 | ITI Dental Implant System | Straumann USA |

Description of the device:

The Leone implant system is composed of a fixture and an abutment joined together by a self locking tapered connection due to a Morse cone and a hexagon. The prosthesis is then placed over the abutment.

## Intended Use:

The Leone Implant System is indicated for single or multiple tooth

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replacement, or for use in terminal or intermediate edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches. The system is designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth. It can work as an abutment system for partial/total prosthetic restorations or as an anchorage system for removable prosthodontics.

Summary of the technological characteristics of our device compared to the predicate device:

| Feature | Leone System | Bicon<br>K994037 | Straumann<br>K031055 |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Designed for use<br>in edentulous sites<br>in the mandible or<br>maxilla for support<br>of a complete<br>denture<br>prosthesis, a<br>terminal or<br>intermediate<br>abutment for fixed<br>bridge work, partial<br>dentures, and / or<br>a single tooth<br>replacement. | Designed for use<br>in edentulous sites<br>in the mandible or<br>maxilla for support<br>of a complete<br>denture<br>prosthesis, a<br>terminal or<br>intermediate<br>abutment for fixed<br>bridge work, partial<br>dentures, and / or<br>single tooth<br>replacement. | Intended for<br>surgical<br>placement in the<br>maxillary and/or<br>mandibular<br>arches to<br>provide support<br>for prosthetic<br>restorations in<br>edentulous or<br>partially<br>edentulous<br>patients. The<br>ITI Dental<br>Implants are for<br>single-stage or<br>two-stage<br>surgical<br>procedures. |
| Material | Titanium | Titanium | Titanium |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |

## Conclusion

Based on the Intended Use, Materials and Biocompatibility, and when it is used, the Leone Implant System is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. The Leone Implant System raises no new issues of safety or effectiveness. Therefore, safety and effectiveness are reasonably assured, and substantial equivalence is supported, justifying 510(k) clearance of the Leone Implant System.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health. The seal is simple and monochromatic.

FEB 2 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Leone SpA C/O Mr. Greg Holland Regulatory Specialists, Incorporated 3722 Avenuc Sausalito Irvine, California 92606

Re: K050586

Trade/Device Name: Leone Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 14, 2006 Received: February 15, 2006

Dear Mr. Holland:

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. Holland

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 moun that 1 DT mas may Federal statutes and regulations administered by other Federal agencies. or the Act of any I ederal bakated as requirements, including, but not limited to: registration 1 ou into contify with a 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 CF Part 801), e quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form mode it 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) This fetter wifi anon yourse bogs 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), 11 you desire 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,

Susan Renner

×( 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 Statement

Page 1 of 1

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: _Leone Implant System

Indications For Use:

The Leone Implant System is indicated for single or multiple tooth replacement, or for use in terminal or internediate edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches. The system is designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth. It can work as an abutment system for partial/total prosthetic restorations or as an anchorage system for removable prosthodontics.

Prescription Use \$\boxed{\checkmark}\$ OR
(Per 21 CFR 801.109)

Over-The-Counter Use_ (Optional Format 1-2-96)

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runser

Car Cellers F