(94 days)
The Orthodontic Temporary Anchorage Implant Screws are intended to provide a fixed anchorage point for the attachment of intraoral orthodontic appliances to facilitate the orthodontic movement of teeth. They are intended for temporary use and should be removed after orthodontic treatment has been completed. The screws are intended for single use only.
The Orthodontic Temporary Anchorage Implant Screws are available in three sizes, 6mm, 8mm and 10mm. The head of the screw allows insertion by either a screwdriver type instrument mated with a slot head or a socket driver type instrument matched with the dual socket design. The neck is long enough, with a .022 hole, to engage auxiliaries and short enough to maintain a low profile. The screws are intended for immediate loading and are highly polished to prevent osseointegration. The screws are made from the same materials, 100% biocompatible titanium ASTM F136, as most of the predicate devices and are sold as non-sterile with instructions to use steam sterilization methods or other accepted techniques used by the orthodontist.
This 510(k) summary describes a medical device submission for orthodontic temporary anchorage implant screws and does not include information about acceptance criteria or a study proving device performance against such criteria. The document focuses on establishing substantial equivalence to previously cleared predicate devices.
Therefore, I cannot provide the requested information. The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for test sets.
- Information on experts used to establish ground truth or adjudication methods.
- Details of an MRMC comparative effectiveness study or related effect sizes.
- Results of a standalone algorithm performance study.
- The type of ground truth used (expert consensus, pathology, etc.).
- Sample size for a training set.
- How ground truth for a training set was established.
The 510(k) submission process is primarily about demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical studies if technological characteristics and intended use are similar. In this case, the manufacturer asserts substantial equivalence based on material, design, and function compared to existing devices.
§ 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.