(238 days)
The Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
The Attachment Equator abutments are indicated for the attachment of full or partial dentures to NUVO implants.
The Attachment Removable Prosthesis abutments are indicated for the attachment of full or partial dentures to Nuvo implants.
The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months.
CF Titanium Base for Crown is a titanium abutment placed onto dental implants to provide support for customized prosthetic restorations, as copings or crowns. It is indicated for single-unit restorations, cement-retained or screwretained in aesthetic areas on implants installed in the maxilla or mandible. All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
CF Titanium Base for Bridge is a titanium abutment placed onto dental implants to provide support for customized prosthetic restorations. The CF Titanium Base for Bridge is indicated for cement or screw-retained multi-unit restorations. All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
The CARES® Abutment CF is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated for screw-retained or cement-retained single-unit restorations. All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann for manufacturing at a validated milling center.
The NUVO CF Implant System includes Implants, Cover Screws, and Abutments.
Implants are intended for single use, provided sterile via gamma irradiation, manufactured of commercially pure titanium (Grade 4), have a bone level design, apically tapered thread-form with apical cutting flutes, and an internal hexagonal implant-to-abutment interface.
Cover Screws are intended for single use, used to protect the internal geometry of the implants during healing, placed out of occlusion, provided sterile via gamma irradiation or ethylene oxide gas, manufactured of titanium alloy (Ti6Al4V-ELI), and have an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants.
Abutments are intended for single use, provided sterile via ethylene oxide gas (except Cobalt-Chromium UCLA CF and CARES Abutment CF which are non-sterile and must be sterilized before use), manufactured of titanium alloy (Ti6Al4V-ELI) or a combination of POM polymer and cobalt-chromium alloy (CoCr), have a conical format in different diameters, height of cementable area and gingival height, are screw-retained to the implant, provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants, and provided with coronal geometries in rotational (non-indexed) and anti-rotational (indexed) versions.
This document is a 510(k) Premarket Notification from the FDA for a dental implant system. It primarily focuses on demonstrating "substantial equivalence" to previously cleared devices rather than presenting a standalone study with specific acceptance criteria and performance data for a novel AI/device.
Therefore, the information required to answer your prompt, particularly regarding AI performance metrics, expert consensus, sample sizes for training/test sets, and MRMC studies, is not present in the provided text. The text details comparisons of technological characteristics and indications for use between the proposed device and predicate devices.
However, I can extract the information that is available regarding the device's validation:
Acceptance Criteria & Device Performance (Based on provided document, not AI-specific)
The document primarily focuses on demonstrating substantial equivalence to predicate devices. This means the "acceptance criteria" are implied to be that the proposed device performs comparably to the predicate devices and does not raise new questions of safety or effectiveness. Specific performance data in the traditional sense of an AI study (e.g., accuracy, sensitivity, specificity) is not provided, as this is a medical device clearance, not an AI model validation report.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Summary from "Equivalence Discussion") |
|---|---|
| Intended Use Equivalence: Subject device indications for use are equivalent to or covered by predicate devices. | The implant system is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved. This is equivalent to the primary predicate K193234. |
| Technological Characteristics Equivalence: Key design features, materials, and manufacturing processes are substantially equivalent to predicate devices. | Implants: Identical bone level design, internal hex interface, apically tapered dual helix thread design, sandblasted and acid-etched surface, commercially pure titanium (Grade 4) material, single-use, gamma irradiation sterilization. Diameters and lengths are equivalent or within the range of predicate devices. |
Abutments (various types): Generally equivalent in implant-to-abutment interface, single-use, material (Ti6Al4V-ELI, CoCr with POM). Coronal and apical geometries are similar to predicate devices. Sterilization methods are identical (Ethylene Oxide or non-sterile/user-sterilized with validated moist heat parameters). Surface treatments are identical (machined, electrolysis, or TiN coating).
Temporary Abutments: Equivalent design and materials, identical sterilization and surface treatment.
CAD/CAM Restorations: Subject devices (Titanium Base for Crown/Bridge) support the same CAD/CAM restoration angulation (up to 30°) and materials (e.g., CoCr, Zerion LT, Polycon ae) as predicates, with similar minimum thickness requirements. The Polycon ae material's 180-day in-mouth indication is consistent. |
| Biocompatibility: Device materials are biocompatible. | Biocompatibility was leveraged from the primary predicate K193234 and reference predicate K173961 (guided by ISO 10993-1 and FDA guidance). |
| Packaging & Stability: Package integrity and product stability are maintained. | Package transport integrity testing performed per ISTA 2A. Product and package stability validated per ASTM F1980. |
| Bench Testing: Device meets mechanical performance requirements. | Dynamic fatigue test per ISO 14801 and FDA guidance was performed for worst-case constructs. MRI compatibility testing was leveraged from reference device K182620. |
| Sterilization: Sterilization processes are validated to an appropriate Sterility Assurance Level (SAL). | Implants: Gamma irradiation validated per ISO 11137-1/2 to SAL of 1 x 10^-6. Abutments: Ethylene oxide gas validated per ISO 11135 to SAL of 1 x 10^-6. Non-sterile components (e.g., Cobalt-Chromium UCLA CF) validated for user sterilization (moist heat) to SAL of 1 x 10^-6. Ethylene oxide residuals assessed per ISO 10993-7 (within limits). Bacterial Endotoxin Testing (
§ 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.