(80 days)
Nobel Biocare's SFB and CFB implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's SFB and CFB implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's SFB and CFB implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
Nobel Biocare TiUnite® Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. The SFB and CFB implants are manufactured from commercially pure titanium. The implants utilize the TiUnite surface treatment and have the Groovy groove design feature.
Nobel Biocare SFB and CFB implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be immediately loaded following insertion where good initial stability can be obtained.
I am sorry, but based on the provided text, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria. The document is a 510(k) summary for dental implants, which primarily focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.
The document describes:
- Device: SFB & CFB Implants
- Intended Use: Endosseous dental implants to support prosthetic devices.
- Predicate Devices: TiUnite Implants (K050705) and Groovy Implants (K050258).
There is no mention of:
- Specific acceptance criteria.
- Performance metrics (e.g., accuracy, sensitivity, specificity).
- Any study design (e.g., sample size, data provenance, ground truth establishment, expert adjudication).
- MRMC or standalone AI studies.
The letter from the FDA confirms that they have reviewed the 510(k) and found the device substantially equivalent to the predicate devices for its stated indications for use. This process relies on demonstrating similarity to already legally marketed devices, not necessarily on new performance studies against predefined acceptance criteria for the new device as would be the case for novel AI/ML devices or other complex technologies requiring extensive performance validation.
§ 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.