K Number

Device Name

LEONE MONOIMPLANT FOR O-RING OVERDENTURE

Manufacturer

LEONE SPA

Date Cleared

2007-04-19

(58 days)

Product Code

DZE

Regulation Number

872.3640

Intended Use

The Leone Monoimplants for O-ring overdenture are indicated as therapy for the stabilization of removable prosthesis on lower arch. The Leone Monoimplants for O-ring overdenture are designed to be surgically inserted in the bone structure of the mouth, exclusively in the mandible at the level of the area between the two foramina, as an anchorage system for total removable prosthesis. To properly support a removable prosthesis, four monoimplants have to be inserted.

Device Description

The Leone Monoimplant for O-ring overdenture is a one-piece endosseous dental implant where an endosseous portion and an abutment portion are defined. The implant is composed of titanium alloy for surgical use. The endosseous portion is a self-tapping screw with a sandblasted surface, while the abutment portion is made of a smooth tapered neck favouring soft tissues healing and mucosal seal and a ball shape top for the connection to the overdenture's microhousing. The monoimplant is supplied in different sizes and is intended for use in the overdenture O-ring therapy in the treatment of the total lower edentulism.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K031106, K050586

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".

Therapeutic

Yes
The device is indicated as "therapy for the stabilization of removable prosthesis on lower arch" and is used in "overdenture O-ring therapy in the treatment of the total lower edentulism," indicating a therapeutic purpose.

Diagnostic

No
The device is described as an implantable medical device for stabilizing removable prostheses, not for diagnosing conditions or diseases.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical dental implant made of titanium alloy, designed for surgical insertion into bone. It is not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is a dental implant designed to be surgically inserted into the bone structure of the mouth. It is a physical implant, not a tool for analyzing biological samples.
The device description and intended use focus on a surgical procedure and a physical implant. There is no mention of analyzing blood, tissue, or any other bodily fluid or substance.

Therefore, the Leone Monoimplants for O-ring overdenture are a medical device, specifically a dental implant, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DZE

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mouth, exclusively in the mandible at the level of the area between the two foramina

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K031106, K050586

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

Image /page/0/Picture/1 description: The image shows the logo for Leone. The logo is white text on a black oval background. The text is stylized and appears to be a brand name.

Image /page/0/Picture/2 description: The image shows a handwritten alphanumeric string "K070483" with a line underneath it. Below the line, there is another handwritten string that appears to be "1 of 2". The handwriting is in black ink on a white background, and the overall image has a simple, unadorned appearance.

510(k) SUMMARY

Submitter's name: Address:

Leone SpA 50 Via P. a Quaracchi Sesto Fiorentino, Italy I-50019 Phone +39.055.30441 Fax +39.055.374808

APR 1 9 2007

Name of contact person:

Elia Ladani Leone SpA 50 Via P. a Quaracchi Sesto Fiorentino. Italy I-50019 quality@leone.it Phone +39.055.30441 Fax +39.055.304444

Date the summary was prepared: February 8, 2007

Name of the device: Trade or proprietary name: Common or usual name: Classification name:

Leone Monoimplant for O-ring overdenture Leone Monoimplant for O-ring overdenture Dental implant Endosseous Dental Implant

The legally marketed device to which we are claiming equivalence [21 CFR 807.92(a)(3)]:

Imtec Corporation, IMTEC Sendax MDI and MDI Plus (K031106) Leone SpA, Leone Implant System (K050586)

Description of the device:

Intended use:

The Leone Monoimplants for O-ring overdenture are indicated as therapy for the stabilization of removable prosthesis on lower arch. The Leone Monoimplants for O-ring overdenture are designed to be

surgically inserted in the bone structure of the mouth, exclusively in the mandible at the level of the area between the two foramina, as an anchorage system for total removable prosthesis. To properly support a removable prosthesis, four monoimplants have to be inserted.

predicate devices:
Device
Name	Leone
Monoimplant for
O-ring
overdenture	IMTEC Sendax
MDI and MDI Plus	Leone
Implant System
Product code	DZE	DZE	DZE
Regulation no.	872.3640	872.3640	872.3640
Applicant	Leone SpA
(Italy)	Imtec Corporation
(USA)	Leone SpA
(Italy)
510(k)	This submission	K031106	K050586
Intended use	The Leone
Monoimplants
for O-ring overdenture
are designed to be
surgically inserted in
the bone structure of
the mouth, exclusively
in the mandible at the
level of the area
between the two
foramina, as an
anchorage system for
total removable
prosthesis.	The IMTEC Sendax
MDI and MDI PLUS
are self-tapping
titanium threaded
screws indicated for
long-term intra-bony
applications.
Additionally, the MDI
may also be used for
inter-radicular
transitional
applications.	The Leone Implant
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
prosthesis.
Material	Titanium Alloy	Titanium Alloy	Titanium Alloy
Biocompatibility	Biocompatible	Biocompatible	Biocompatible
Sterility	Sterile	Sterile	Sterile

Summary of the technological characteristics of our device compared to the redicato davings:

Conclusion:

The Leone Monoimplant for O-ring overdenture intended use is equivalent to the IMTEC Sendax MDI and MDI Plus long-term application and to the Leone Implant System anchorage for removable prosthesis in case of the stabilization of an overdenture. The Leone Monoimplant for O-ring overdenture and the predicate devices are composed of the same biocompatible titanium alloy for surgical use, they are substantially equivalent in design, physical characteristics, functional performance, labelling, potential adverse effects. Based on the information provided herein, we conclude that the Leone Monoimplant for O-ring overdenture is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. The Leone Monoimplant for O-ring overdenture 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 Monoimplant for O-ring overdenture.

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three bars representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Elia Ladani Quality Manager Leone SpA 50 Via P. a Quaracchi Sesto Fiorentino, ITALY I-50019

APR 1 9 2007

Re: K070483

Trade/Device Name: Leone Monoimplant for O-ring Overdenture Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: April 10, 2007 Received: April 12, 2007

Dear Mr. Ladani:

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.

Page 2 - Mr. Ladani

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 (OS) 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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sayite Y. Michuomd
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

INDICATIONS FOR USE STATEMENT

K070483

510(k) Number (if known):

Device Name: Leone Monoimplant for O-ring overdenture

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kei Muly for MSR

Memorial Hospital
ion Control, Central Devices

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Leone SpA, Sesto Fiorentino - Italy

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