(276 days)
Intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures. It is used temporarily and is removed after orthodontic treatment has been completed. Plates, screws, and pilot drills are intended for single use only.
This submission describes the OsteoMed Orthodontic Anchor Plating System which includes plates intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures. It is used temporarily and is removed after orthodontic treatment has been completed. The OsteoMed Orthodontic Anchor Plates are intended for single use only. The OsteoMed Orthodontic Anchor Plating System plates are provided in various shapes and sizes and are fixed to bone via Auto-Drive screws.
The provided text describes a 510(k) submission for the OsteoMed Orthodontic Anchor Plating System. This type of submission relies on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device performance, sample sizes, ground truth establishment, or expert involvement in the evaluation of device performance against predefined criteria.
The 510(k) summary explicitly states:
"Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS-Martin Ortho Anchorage System (K040891) and the Stryker Leibinger Skeletal Anchoring System (K041651). Due to the similarity of materials and design to the predicate devices, OsteoMed believes that the OsteoMed Orthodontic Anchor Plating System does not raise any new safety or effectiveness issues."
This indicates that the submission's focus was on demonstrating that the new device is substantially equivalent to already legally marketed devices, and therefore, does not necessitate a new study to prove its performance against specific 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.