(357 days)
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.
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.
The provided text describes a 510(k) premarket notification for the "Leone Implant System," a dental implant device. The submission focuses on establishing substantial equivalence to existing legally marketed predicate devices rather than proving specific performance criteria through a study with acceptance criteria.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided document.
The document states that the conclusion is based on:
- Intended Use: Consistent with predicate devices.
- Materials: Titanium (same as predicate devices).
- Biocompatibility: Biocompatible (same as predicate devices).
The acceptance criteria for a 510(k) submission like this are primarily demonstrating that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use, technological characteristics, and raises no new questions of safety or effectiveness.
Summary of what is present:
- Acceptance Criteria and Reported Device Performance: Not presented as a list of quantitative metrics. The "acceptance criteria" are effectively demonstrating substantial equivalence in intended use, material, and biocompatibility, which the submitter claims is met.
- Study Details: No study is described that tests the device against specific performance acceptance criteria. The submission is a comparison to predicate devices.
- Sample Size for Test Set: Not applicable, as no performance study is detailed.
- Data Provenance: Not applicable.
- Number of experts and qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC study: Not applicable.
- Standalone performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
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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: 949-262-0411
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 | BiconK994037 | StraumannK031055 |
|---|---|---|---|
| Intended Use | Designed for usein edentulous sitesin the mandible ormaxilla for supportof a completedentureprosthesis, aterminal orintermediateabutment for fixedbridge work, partialdentures, and / ora single toothreplacement. | Designed for usein edentulous sitesin the mandible ormaxilla for supportof a completedentureprosthesis, aterminal orintermediateabutment for fixedbridge work, partialdentures, and / orsingle toothreplacement. | Intended forsurgicalplacement in themaxillary and/ormandibulararches toprovide supportfor prostheticrestorations inedentulous orpartiallyedentulouspatients. TheITI DentalImplants are forsingle-stage ortwo-stagesurgicalprocedures. |
| 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runser
Car Cellers F
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.