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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.

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