(135 days)
The IS-III active System S-narrow Type is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
The IS-III active System S-narrow Type is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
IS-III active System_S-Narrow System is composed of IS-III active S-Narrow Type fixtures and Abutments. IS-III active Fixture S-Narrow Type is a thread type implant made of Titanium ELI according to ASTM F136 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex.
Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body.
The Fixture's diameters are 3.2 mm and the lengths are 8.5/10.0/11.5/ 13.0/ 15.0 mm. Tolerance of dimension shall be within ± 1% range.
IS-III active System S-Narrow Type Abutments are composed as below: IS Cover Screw, IS Healing Abutment, IS Cemented Abutment, IS Temporary Abutment and IS Abutment Screw
This document is a 510(k) Premarket Notification from the FDA, asserting the substantial equivalence of the Neobiotech IS-III active System S-narrow Type dental implant system to legally marketed predicate devices.
This document describes a premarket notification for a dental implant system. It does NOT contain information about an AI/ML-driven medical device or a study involving human-in-the-loop performance, expert consensus, or ground truth establishment for a test set.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as this document does not pertain to such a device or study.
The provided document focuses on:
- Device Description: What the dental implant system is composed of (fixtures, abutments, screws), materials used (Titanium ELI), dimensions, and surface treatments.
- Indications for Use: Where and how the device is intended to be used in dental procedures.
- Substantial Equivalence Comparison: A detailed comparison of the subject device (IS-III active System S-narrow Type) with various predicate devices (both primary and reference predicates) across technological characteristics such as device name, classification, materials, design, dimensions, surface treatment, sterilization, and principle of operation.
- Non-Clinical Testing Data: A list of performance tests conducted on the subject device (e.g., sterilization validation, shelf life, bacterial endotoxin) and tests leveraged from predicate devices (e.g., biocompatibility testing). The conclusion states that these tests met the criteria of the standards and demonstrated substantial equivalence.
Without information on an AI/ML component or a clinical study that evaluates its performance against acceptance criteria using a human-in-the-loop or standalone approach, I cannot fulfill the request for the specific points listed.
§ 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.