(267 days)
Anker II Dental Implant System is intended to be surgically placed in the alveolar bone of upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
Anker II Dental Implant System is intended for delayed loading. No matter placing implants in anterior or posterior region, we recommend choosing the diameter of implants as large as possible. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).
Specific indications for small diameter (≥03.3mm) and short (length ≤ 7mm) dental implants: Because of their reduced mechanical stability, small diameter and short implants are only used in cases with a low mechanical load. We recommend only used in the maxillary lateral incisor or the mandibular central incisors.
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This document does not contain the information requested for acceptance criteria and the study proving a device meets those criteria.
The provided text is a 510(k) Premarket Notification from the FDA for a dental implant system (Anker II Dental Implant System). It states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices.
This type of FDA letter focuses on:
- Substantial Equivalence determination: This means the FDA believes the new device is as safe and effective as a legally marketed predicate device, and thus does not require a full Premarket Approval (PMA) application.
- Regulatory information: It outlines the relevant regulations (e.g., general controls, manufacturing practices, labeling) that the device manufacturer must comply with.
- Indications for Use: It explicitly states what the device is intended for.
What is missing from this document for your request:
- Acceptance Criteria Table: There is no table defining specific performance metrics (e.g., accuracy, precision, strength, biocompatibility thresholds) that the device must meet.
- Reported Device Performance: No actual performance data from a study (e.g., tensile strength, fatigue testing results, clinical outcome data) is provided. The letter only refers to the device being "substantially equivalent."
- Study Design Information: There is no mention of:
- Sample sizes for test sets or training sets.
- Data provenance (country, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication methods.
- MRMC studies, effect sizes, or even if an AI component is involved (this is a traditional dental implant, not an AI device).
- Standalone performance.
- Type of ground truth used or how it was established.
In summary, this document is an FDA clearance letter based on substantial equivalence, not a detailed technical report or study describing 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.