(74 days)
The ITI synOcta angled abutments for Wide Neck Implants are indicated for use in cases where the placement of an implant requires an angled reconstruction for an optimal result. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
The ITI Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The devices covered by this submission are angled abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The angled abutment is used for angulation correction in cases where the position of the dental implant requires an angled reconstruction for an optimal restoration.
The 15° synOcta angled abutment for the Wide Neck Implant is made from commercially pure Grade 4 titanium (F67). The basal portion of the abutment has an 8° conical taper with an inset octagonal design. The abutment is seated in the implant with a screw, which is mounted in the basal portion of the abutment. The abutment is used for cemented restorations.
This document is a 510(k) premarket notification for a medical device and does not contain information about acceptance criteria or a study proving the device meets them. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information, which typically comes from performance studies.
Here's why the document doesn't contain the requested information:
- Substantial Equivalence: The primary purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is often done by comparing design, material, intended use, and performance characteristics, rather than conducting new clinical trials or extensive performance studies with predefined acceptance criteria.
- Focus on Design and Material: The document explicitly states that "The ITI synOcta angled abutments for the Wide Neck Implant are substantially equivalent in intended use, material, and design to the ITI synOcta angled abutments cleared under K994119." This indicates that the equivalence is based on these aspects, not necessarily on new performance data against specific acceptance criteria.
- No Performance Study Description: There is no section describing a study conducted to test the device's performance against specific metrics. The document details the device's description and intended use but not any testing methodology, results, or acceptance thresholds.
§ 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.