(268 days)
Not Found
No
The summary describes a physical implant device and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as an "orthodontic mini implant" used to facilitate "orthodontic movement of the teeth," which is a therapeutic intervention.
No
The device is described as an orthodontic mini implant used for anchoring orthodontic appliances to facilitate tooth movement. Its function is to provide a fixed anchor, not to diagnose a condition.
No
The device description clearly states it is a physical implant made of stainless steel for surgical use, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The Leone orthodontic mini implant is a physical implant device made of stainless steel that is surgically placed inside the body (in vivo) in the maxillary and mandibular bone.
- Intended Use: Its purpose is to provide anchorage for orthodontic appliances to facilitate tooth movement, which is a mechanical process happening within the body.
The description clearly indicates a surgically implanted device used for mechanical support within the body, not for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The Leone orthodontic mini implant is an implant device providing a fixed anchorage for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily in the maxillary and mandibular bone and must be removed after orthodontic treatment has been completed.
Product codes
DZE, OAT
Device Description
The Leone orthodontic mini implant is a medical device made of stainless steel for surgical use (ISO 5832-1). The orthodontic mini implant is a one-piece endosseous mini implant where the endosseous portion is a right-hand thread screw, while the head section is made of a smooth tapered neck. It is available in different diameters, lengths and head shapes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and mandibular bone
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for Leone. The logo is in an oval shape with the word "leone" written in a stylized font. The background of the oval is black, and the text is white. The logo has a distressed or vintage look.
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
1 : 22
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: August 3, 2007
Name of the device: Trade or proprietary name: Common or usual name: Classification name:
Leone orthodontic mini implant Leone orthodontic mini implant Orthodontic implant Endosseous Dental Implant
The legally marketed device to which we are claiming equivalence [21 CFR 807.92(a)(3)):
Dentos Inc, Dentos AbsoAnchor orthodontic microimplant (K060126)
Description of the device:
The Leone orthodontic mini implant is a medical device made of stainless steel for surgical use (ISO 5832-1). The orthodontic mini implant is a one-piece endosseous mini implant where the endosseous portion is a right-hand thread screw, while the head section is made of a smooth tapered neck. It is available in different diameters, lengths and head shapes.
Intended use:
The Leone orthodontic mini implant is an implant device providing a fixed anchorage for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily in the
Leone SpA, Sesto Fiorentino - Italy
SECTION 5B - Page 1 of 2
1
maxillary and mandibular bone and must be removed after orthodontic treatment has been completed.
Summary of the technological characteristics of our device compared to the predicate device:
| Device Name | Leone orthodontic mini | Dentos AbsoAnchor |
|---|---|---|
| implant | orthodontic microimplant | |
| Product code | DZE | DZE |
| Regulation no. | 872.3640 | 872.3640 |
| Applicant | Leone SpA (Italy) | Dentos, Inc (Korea) |
| 510(k) | This submission | K060126 |
| Intended use | Provide a fixed anchorage | |
| for attachment of orthodontic | ||
| appliances to facilitate the | ||
| orthodontic movement of the | ||
| teeth. It is used temporarily | ||
| in the maxillary and | ||
| mandibular bone and must | ||
| be removed after orthodontic | ||
| treatment has been | ||
| completed. | Provide a fixed anchorage | |
| point for attachment of | ||
| orthodontic appliances to | ||
| facilitate the orthodontic | ||
| movement of the teeth | ||
| Material | Surgical stainless steel ISO | |
| 5832-1 | Surgical titanium alloy ISO | |
| 5832-3 | ||
| Biocompatibility | Biocompatible. | Biocompatible. |
| Sterility | Non-sterile. It is | |
| recommended to sterilize | ||
| with steam autoclave before | ||
| use. | Non-sterile. Steam sterilize | |
| before use. |
Conclusion:
According to the similarities specified in the above comparison table between the current device Leone orthodontic mini implant and the predicate device, in indications for use, technology and performance specifications as supported by the results of the testing performed we conclude that the Leone orthodontic mini implant is substantially equivalent to the Dentos AbsoAnchor orthodontic microimplant, device currently marketed in USA under the Federal Food, Drug and Cosmetic Act.
The Leone orthodontic mini implant 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 orthodontic mini implant.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with flowing ribbons or streamers extending from its body. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 22 2008
Mr. Elia Ladani Quality Manager Leone SpA 50 Via P. a Quaracchi Sesto Fiorentino I-50019 ITALY
Re: K071490
Trade/Device Name: Leone Orthodontic Mini Implant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: February 11, 2008 Received: February 14, 2008
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.
3
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 (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 vour 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Ques
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
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Ko7 1490
Device Name: Leone orthodontic mini implant
Indications For Use:
The Leone orthodontic mini implant is an implant device providing a fixed anchorage for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily in the maxillary and mandibular bone and must be removed after orthodontic treatment has been completed.
Prescription Use 4 (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)
Susan Runse
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K152749
Page _ of _
SECTION 4 - Page 1 of 1