(62 days)
The Tapered Screw-Vent® T Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
The Tapered Screw-Vent® T Implant is an endosseous dental implant. The implant is composed of titanium alloy. The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with triplelead threads.
This document is a 510(k) Pre-Market Notification for a dental implant, the Tapered Screw-Vent® T Implant. It establishes substantial equivalence to existing predicate devices. However, this document does not describe any study that proves the device meets specific performance acceptance criteria based on metrics like accuracy, sensitivity, or specificity.
Instead, the document focuses on:
- Device Description: Describing the Tapered Screw-Vent® T Implant's materials (titanium alloy), design features (tapered with triple-lead threads, treated surface for osseointegration), and size offerings.
- Indications for Use: Stating that the implants are for use in the maxilla or mandible, for immediate or conventional loading, and to replace one or more missing teeth.
- Predicate Device Comparison: Highlighting that the new device is "the same as the predicate Tapered Screw-Vent® Implant in the implant/abutment connection, implant body design, materials, and manufacturing." The only modifications mentioned are the addition of "MTX texture to the top of the implant and add small grooves on the implant collar similar to the predicate NobelReplace Tapered implant."
- Substantial Equivalence Determination: The FDA's letter explicitly states that they have "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."
Therefore, based on the provided text, I cannot provide the requested information regarding acceptance criteria and studies proving performance because:
- No Acceptance Criteria or Reported Device Performance Table: The document does not define specific performance metrics (e.g., success rates, complication rates, osseointegration percentages) or acceptance criteria for those metrics. It assumes performance based on substantial equivalence to predicate devices.
- No Performance Study Described: There is no mention of a study (clinical or otherwise) designed to measure the Tapered Screw-Vent® T Implant's performance against specific endpoints. The FDA's 510(k) clearance process for this type of device often relies on demonstrating substantial equivalence to already cleared devices rather than requiring new clinical performance studies unless the device raises new questions of safety or effectiveness.
In summary, the provided text does not contain the information required to populate the fields of your request. This 510(k) submission relies on substantial equivalence, not a de novo study demonstrating meeting specific performance 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.