(426 days)
Not Found
No
The summary describes a dental implant system made of titanium, focusing on its mechanical properties, sterilization, and packaging. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The device is intended to restore original features and masticatory functions, which qualifies it as a therapeutic device.
No
The device is described as an implant fixture intended to provide support for prosthetics to restore masticatory functions, not to diagnose a condition.
No
The device description explicitly states it is a physical implant fixture made of titanium, intended for surgical placement in bone. It also describes manufacturing materials and sterilization procedures, which are characteristic of a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is surgically placed in the bone to support prosthetics and restore dental function. This is a direct therapeutic intervention within the body.
- Device Description: The description details a physical implant made of titanium, designed for surgical placement.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgically implanted medical device.
N/A
Intended Use / Indications for Use
IMPLUS implant fixtures are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches in order to provide support for fixed and/or removal prosthetics in order to restore original features and masticatory functions.
Implus implant fixtures are indicated for permanent use.
Implus implant fixtures are disposable and are for one-time use only. These fixtures are not to be recleaned or re-sterilized.
Product codes
DZE
Device Description
Leader Italia IMPLUS implants are available in cylindrical or tapered shape, with different dimensions; connection to abutments is made by internal or external hexagon. All implants are manufactured from medical titanium in grade 4 (Ref. ASTM F67) with a modified surface for optimum ostheointegration. The implants are all provided sterile in a packaging complete with mount transfer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Mandibular and/or maxillary dental arches
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Mechanical and fatigue tests performed by "Politecnico di Milano" - Structural Engineering Department - demonstrated stiffness and durability of Leader Italia implants and abutments. The tests were performed on IMPLUS implants diam.4 with 25° angled abutment (report 01/014/rel of 17th December 2001); test method is detailed in Section 18 pages 2, 3, 5 and 6. Performance test and biological analysis demonstrated effectiveness of the sterilization procedure with gamma rays (report by BIOSTER laboratory issued on January 1998) and the packaging duration (5 years) according to results of report issued by BIOSTER on October 2003.
Following the start-up of the new production plant and clean room, new tests for validation of the sterilization procedure and of the packaging duration were performed (Report by BIOSTER laboratory issued on February 2nd 2007 and December 2006 respectively).
In accordance with standard ISO 14801 issued on 2003, laboratory tests were requested to Politecnico di MIlano. Further Fatigue Tests are presently running according to standard ISO 14801; final results are foreseen next April 2007.
Key Metrics
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.
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Section 5 - 510(k) Summary Additional Information
Image /page/0/Picture/2 description: The image shows the word "LEADER" with vertical lines separating each letter. Below each letter is another letter, "J T A L I A". The letters are all in a sans-serif font and are black on a white background. The image is simple and clear.
KOLO 2931
510(k) Summary (21 CFR 807.92) LEADER ITALIA IMPLANTS
I General Information
| Submitter: | LEADER ITALIA S.r.l.
Via Aquileja, 49
Cinisello Balsamo (MILANO) ITALY | |
|------------------------------|------------------------------------------------------------------------------|--------------|
| Telephone: | +39 02 618651 - Company Number
+39 02 61865368 - Contact Person | |
| Fax: | +39 02 61290676 | |
| Contact Person: | Mariaelena Costantin
Export Manager | NOV 2 8 2007 |
| Summary Preparation Date: | March 22nd, 2007 | |
| Names | | |
| Device Name: | IMPLUS
Endosseous Dental Implant | |
| Primary Classification Name: | DZE - Implant, Endosseous, Root-Form | |
III Predicate Devices
प्र
| • Sulzer Dental Screw-Vent Dental Implant System (K011028) | vs IMPLUS |
|---|---|
| • Branemark Integration Endosseous Implant (K021355) | vs IMPLUS |
IV Product Description
Leader Italia IMPLUS implants are available in cylindrical or tapered shape, with different dimensions; connection to abutments is made by internal or external hexagon. All implants are manufactured from medical titanium in grade 4 (Ref. ASTM F67) with a modified surface for optimum ostheointegration.
LEADER ITALIA Srl Via Aquileja 49 20092 Cinisello Balsamo (MI) Phone (+39) 02 618651 Fax (+39) 02 61290676 E-mail export@leaderttalia.it
1
The implants are all provided sterile in a packaging complete with mount transfer.
IMPLUS Implants List:
| SHAPE | HEXAGON | DIAMETER | LENGTH |
|---|---|---|---|
| Cylindrical | Internal | 3,3 mm | 8-10-11,5-13-16 mm |
| Cylindrical | Internal | 3,75 mm | 8-10-11,5-13-16 mm |
| Cylindrical | Internal | 4,5 mm | 8-10-11,5-13-16 mm |
| Cylindrical | Internal | 5,5 mm | 8-10-11,5-13 mm |
| Cylindrical | External | 3,3 mm | 10-11,5-13-15 mm |
| Cylindrical | External | 3,75 mm | 8-10-11,5-13-15-18-20 mm |
| Cylindrical | External | 5 mm | 8-10-11,5-13 mm |
| Tapered | Internal | 4 mm | 8-10-11,5-13-16 mm |
| Tapered | Internal | 5 mm | 8-10-11,5-13-16 mm |
| Tapered | Internal | 6 mm | 8-10-11,5-13 mm |
| Tapered | External | 4 mm | 8-10-11,5-13-15 mm |
| Tapered | External | 5 mm | 8-10-11,5-13 mm |
V Indications for Use
IMPLUS implant fixtures are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches in order to provide support for fixed and/or removal prosthetic in order to restore original features and masticatory functions. Implus implant fixtures are foreseen for permanent use. These fixtures are disposable and are for one-time use only. These fixtures are not to be re-cleaned or re-sterilized.
Leader Italia Implus implants can support a single tooth, more dental elements or total prosthesis.
If we loose a tooth, we can replace it without damaging the two close teeth when building the so called traditional "bridge". The use of the implant allows us to obtain an optimal aesthetic and functional result. In fact, once the implant has been inserted in the bone, it rapidly becomes an integral part of it and it will become the artificial root on which the artificial tooth will be fastened.
If the missing teeth are more than one, the use of multiple implants allows us a sufficient number of artificial roots on which to fasten the necessary artificial teeth to complete the dental arch. In this way, the use of removable prosthesis with metal base (the so - called "plate") is avoided as well as the use of healthy teeth as abutment for a bridge. In this
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L E A D E R
situation, the obtained results offers more comfort for the patient together with aesthetics and functionality and less reduction of tooth structure.
The choice of the implants is recommended also in case of total teeth absence on one or both of the dental arches. According to circumstances the dentist will consider how many implants should be inserted in the bone and whether to use a fixed or a movable prosthesis. In both cases, the prosthesis on implants have complete stability in all functions - such as speaking, smiling, chewing - and reduce the precarious stability problems that can be found in the traditional total prosthesis.
Safety and Effectiveness Information VI
Leader Italia implants have been manufactured and marketed in several countries (Italy, India, Poland Spain, Philippines, Estonia, Lithuania and more others) for years, and our customers found them to be safe and effective products, substantially equivalent to similar devices manufactured by competitors .
Biocompatibility: Implus Implants are made of Medical Titanium grade 4 (ASTM F67), abutments are made of Titanium grade 5 (ASTM F136-96).
This material is commonly used by manufacturer of dental implants following the widely recommended as the most suitable raw materials for contact with human tissue.
Leader's implants were also tested and found to be not cytotoxic according to standard UNI EN ISO 30993 part 5 of September 2000 by "BIOLAB" laboratory, Vimodrone, Milano, Italy (report nº SAM1282 dated 11th February 2003)
Mechanical and fatigue tests performed by "Politecnico di Milano" - Structural Engineering Department - demonstrated stiffness and durability of Leader Italia implants and abutments.
The tests were performed on IMPLUS implants diam.4 with 25° angled abutment (report 01/014/rel of 17th December 2001); test method is detailed in Section 18 pages 2, 3, 5 and 6. Performance test and biological analysis demonstrated effectiveness of the sterilization procedure with gamma rays (report by BIOSTER laboratory issued on January 1998) and the packaging duration (5 years) according to results of report issued by BIOSTER on October 2003.
Additional information:
Following the start-up of the new production plant and clean room, new tests for validation of the sterilization procedure and of the packaging duration were performed (Report by BIOSTER laboratory issued on February 2nd 2007 and December 2006 respectively).
In accordance with standard ISO 14801 issued on 2003, laboratory tests were requested to Politecnico di MIlano. Further Fatigue Tests are presently running according to standard ISO 14801; final results are foreseen next April 2007
3
Image /page/3/Picture/2 description: The image shows the word "LEADER" with a vertical line separating each letter. The letters are in a bold, sans-serif font. Below each letter is a smaller letter, which appears to be a key or label for the letter above.
VII Conclusion
Based on comparison to the predicate devices, we conclude that the products are substantially equivalent to currently marketed devices under the Federal Food, Drug and Cosmetic Act and presents no concerns about safety and effectiveness.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to serving all Americans. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a sans-serif font. The text is arranged around the top and left side of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2007
LEADER Italia S.r.1. C/O Mr. Henry J. Vogelstein Consultant 1349 Lexington Avenue New York, New York 10128
Re: K062931
Trade/Device Name: IMPLUS Regulation Number: 21 CFR 872,3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 19, 2007 Received: October 22, 2007
Dear Mr. Vogelstein:
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. Vogelstein
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 (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,
Chiu-Ling, 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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Indications for Use
510(k) Number (if known):
IMPLUS Device Name:
Indications for Use:
IMPLUS implant fixtures are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches in order to provide support for fixed and/or removal prosthetics in order to restore original features and masticatory functions.
Implus implant fixtures are indicated for permanent use.
Implus implant fixtures are disposable and are for one-time use only. These fixtures are not to be recleaned or re-sterilized.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Part 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Ken Ruby for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K062931
LEADER ITALIA Srl Via Aquileja 49 20092 Cinisello Balsamo (MI) Phone (+39) 02 618651 Fax (+39) 02 61290676 E-mail export@leaderitalia.it