(275 days)
The Nobel Direct 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelDirect 3.0 Implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.
Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.
Nobel Biocare's NobelDirect 3.0 Implant is a threaded one-piece root form endosseous implant with an integrated abutment designed for one-stage surgical procedures. The NobelDirect 3.0 is 3.0mm in diameter and available in lengths of 13mm and 15mm.
The provided text is a 510(k) summary for a dental implant, K070857 NobelDirect 3.0 - Immediate Load. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, focusing on device description, indications for use, and a comparison to the predicate. It does not typically include detailed performance study results, acceptance criteria, or an in-depth analysis of AI components because it's for a traditional medical device, not an AI/ML-driven diagnostic or therapeutic device.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for AI model training. These elements are relevant for AI/ML device submissions, which this is not.
The document only provides the following:
1. Device Information:
- Submitted by: Herbert Crane, Nobel Biocare USA LLC
- Device Name: NobelDirect 3.0 - Immediate Load
- Classification Name: Endosseous Dental Implant (21 CFR 872.3640)
- Legally Marketed Device(s) (Predicate): NobelDirect (K031345)
- Device Description: A threaded one-piece root form endosseous implant with an integrated abutment, 3.0mm in diameter, available in 13mm and 15mm lengths.
- Indications for Use: For missing maxillary lateral incisors or mandibular central and lateral incisors to support prosthetic devices in partially edentulous patients. May be put into immediate function if stability requirements are met. Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.
This submission is a regulatory approval for a physical dental implant, not a software or AI-driven diagnostic device.
§ 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.