(90 days)
The STA abutment system is indicated for use on properly placed and healed dental implants, to extend the coronal aspect of the implant through soft gingival tissues into the oral cavity to provide the attachment mechanism for cement retained, single tooth restorations to restore a patient's chewing function.
The STA System is a multi-component system consisting of abutment cylinders/screws, temporary cylinders for provisional components, healing Caps, temporary copings, laboratory analogs and gold copings (cylinder) for cement retained restorations. The STA system is not significantly different from other 3i abutment systems except that it is designed specifically for single tooth CEMENT RETAINED RESTORATIONS. The STA system is designed to be used with standard size implants and is offered in an assortment of transmucosal tissue heights. The abutment cylinder also incorporates 3i's "Standard ZR" minimal micro-movement design which permits a tighter fit between components, further reducing inter-component "micro-movement", often attributed to abutment screw loosening and fracture.
The provided document, K965077, is a 510(k) Pre-Market Notification for 3i Implant Innovations' Single Tooth Abutment System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials and detailed acceptance criteria against performance goals. Therefore, the document does not contain the specific information requested in the prompt.
Here's a breakdown of why the requested information cannot be extracted from this document:
- Acceptance Criteria and Reported Device Performance: A 510(k) submission generally does not define specific "acceptance criteria" for performance metrics in the way a clinical trial for a novel device would. Instead, it argues that the new device performs as well as or in a similar manner to a predicate device. The document mostly describes the device's components, materials, and intended use, comparing it to existing 3i abutment systems and Nobel Bio-Care's "Cera-One". There are no reported performance metrics for the device against specific quantitative criteria.
- Study Details (Sample Size, Data Provenance, Expertise, Adjudication, MRMC, Standalone, Ground Truth): This document does not describe a study in the sense of a clinical trial used to prove device performance. It is a regulatory submission for substantial equivalence. Therefore, there is no information on:
- Sample size for test sets.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance (as this is a physical medical device, not an AI algorithm).
- Type of ground truth used (pathology, outcomes data, etc.).
- Sample size for a training set (not applicable).
- How ground truth for a training set was established (not applicable).
Summary of available information related to equivalence:
The document asserts substantial equivalence based on:
- Similar Materials: The STA System is constructed of titanium or titanium alloy, similar to other 3i abutment systems and the predicate devices (except for Nobel Bio-Care's use of plastics in some components). The Uniscrew uses Titanium Alloy and Gold/Palladium Alloy.
- Similar Design: The STA System is described as not significantly different from other 3i abutment systems, specifically designed for single tooth cement-retained restorations. It incorporates a "Standard ZR" minimal micro-movement design for a tighter fit, reducing inter-component micro-movement.
- Similar Indications for Use: The STA System is indicated for use in cement-retained, single-unit restorations, which does not substantially differ from Nobel Bio-Care or other 3i abutment systems.
- Predicate Devices: The 3i STA Abutments are claimed to be substantially equivalent to 3i's Standard, Tapered or Conical Abutment systems, 3i's Abutment Posts, and Nobel Bio-Care's "Cera-One" abutment systems.
In conclusion, this document serves as a regulatory submission for a physical medical device. It focuses on demonstrating equivalence to already approved devices rather than presenting data from a performance study against predefined acceptance criteria.
§ 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.