(300 days)
INDICATIONS FOR USE: The Transitional Implants are designed for temporary use in edentulous sites. The primary purpose is to provide provisional prosthetic devices to protect the permanent implants from premature loading during the healing period. They are used to support bridges and dentures. Additional uses are inter-radicular transitional applications, immediate splinting stability, full and partial edentulism and using minimally invasive surgical interventions. The target population is determined when there is inadequate bone for wider implants as well as for patients wishing immediate functional loading. The transitionals are to be used in a clinical site by a qualified dentist experienced in placing dental implants.
This transitional implant is designed to serve as a provisional artificial root to provide immediate load support for permanent implants. They are manufactured using 6/4 Titanium alloy 90% titanium 6% aluminum and 4 % vanadium for strength. The implants are grit blasted . The diameter is 2.5mm and the Lengths are 10mm,(SM3002, 13mm (SM3003) and 15 mm (SM3004). The implants are designed as one piece with a ball abutment on one end at the top of the implant. The ball fits into a rubber o-ring and keeper in the prosthesis which is designed for retention.
This 510(k) summary (K073645) for Simpler Mini Implants does not contain the information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The document primarily focuses on:
- Device Description: What the Simpler Mini Implants are made of and their physical characteristics.
- Indications for Use: The intended applications for the implants (temporary use, supporting bridges and dentures, etc.).
- Predicate Device: Information about legally marketed devices to which Simpler Mini Implants are claiming equivalence.
- Regulatory Classification: The device's classification (Class II, Special Controls).
- FDA Communication: The letter from the FDA stating substantial equivalence.
The "SUMMARY OF TESTING" section explicitly states: "Simpler transitional implants do not introduce new issues for testing from other Simpler implants for materials, surface treatment, fatigue testing and sterilization." This implies that the testing performed was likely related to these specific engineering aspects for equivalence and not clinical performance or diagnostic accuracy.
Therefore, I cannot populate the table or answer the other questions based on the provided text. The document does not describe a study that proves the device meets specific acceptance criteria in the context of clinical performance or a diagnostic AI system, nor does it refer to data provenance, expert ground truth establishment, or comparative effectiveness studies.
§ 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.