(84 days)
Straumann® Bone Level Tapered Implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann Bone Level Tapered Implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).
The subject devices represent a line extension of the previously cleared Bone Level Tapered Implants of the Straumann Dental Implant System (K140878 and K150938). The subject devices have the same diameters (3.3, 4.1 and 4.8 mm), the same implant-to-abutment interfaces (NC, RC), the same material (Ti-13Zr) and the same surface finishes (SLA, SLActive) as the identified primary predicate devices. The subject devices differ in that the lengths are 18 mm versus a maximum length for the primary predicate devices of 16 mm.
This document describes the Straumann® Bone Level Tapered Implants, a line extension of existing dental implants. The new implants are identical to previously cleared devices except for an increased length (18mm vs. previous maximum of 16mm).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the new 18mm implant length in a quantitative format as would typically be seen for AI/ML device performance. Instead, it relies on comparison to predicate devices and performance of specific bench tests. The primary acceptance criteria for the new device appear to be:
- Substantial Equivalence: The subject device is substantially equivalent to the identified predicate devices in terms of indications for use, technological characteristics (except length), and performance.
- Safety and Effectiveness through Bench Studies: The device must satisfactorily address safety and effectiveness through relevant bench studies, particularly dynamic fatigue, biological compatibility, sterilization validation, and shelf life, consistent with FDA guidance and ISO standards.
- No New Failure Modes: The new, longer implants, especially the smallest diameter (3.3mm), must not introduce new failure modes compared to predicate or reference devices when tested under simulated clinical conditions.
| Acceptance Criterion | Reported Device Performance/Findings |
|---|---|
| Substantial Equivalence to Predicate Devices (K140878, K150938) | The subject devices are stated to be "identical in every respect to the identified Bone Level Tapered predicate devices with the exception of overall length". |
| Dynamic Fatigue Test (consistent with FDA guidance and ISO 14801) | Incorporated by reference to primary predicate (K140878). Implies the predicate met this, and by extension, the new device, being identical except length, is considered to meet it. |
| Biological Compatibility (per ISO 10993 series standards) | Incorporated by reference to primary predicate (K140878). Implies the predicate met this, and by extension, the new device, using the same materials, is considered to meet it. |
| Sterilization Validation (per ISO 11137 series standards) | Incorporated by reference to primary predicate (K140878). Implies the predicate met this. |
| Shelf Life (stability) (per ASTM F1980) | Incorporated by reference to primary predicate (K140878). Implies the predicate met this. |
| No new failure modes due to reduced minimum implant diameter (Ø3.3 mm vs. Neodent CM Drive Ø3.5 mm) - specifically for peak insertion torque while driving implants into simulated bone. | Peak insertion torque was measured on all three diameters (3.3, 4.1, 4.8 mm) of the subject device in polyurethane foam of varying densities. The conclusion states that based on the assessment of design and performance data, the devices are substantially equivalent. This implies no new failure modes were identified. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of devices or clinical cases. The "test set" here refers to the samples used in the bench studies.
- For the peak insertion torque study: "all three diameters of the subject device" were tested. It is not specified how many samples per diameter were tested.
- For the studies incorporated by reference (dynamic fatigue, biological compatibility, sterilization, shelf life), the sample sizes are not provided in this document but would have been part of the K140878 submission.
- Data Provenance: Bench studies. There is no indication of human clinical data or geographical origin for this specific submission, as it focuses on extended length and comparison to predicates through bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this submission. The "ground truth" for these types of mechanical and biological tests is derived from standardized testing methods and material properties, not expert clinical interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for studies involving human reviewers or subjective interpretations. The studies described are objective bench tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
Not applicable. This device is a physical dental implant, not an AI/ML-driven diagnostic or assistive software. Therefore, no MRMC or AI-related studies were performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is not an AI/ML device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance claims in this submission is established through:
- Standardized Bench Testing: Adherence to international standards (e.g., ISO 14801, ISO 10993, ISO 11137, ASTM F1980) for mechanical strength, biocompatibility, sterilization, and stability.
- Material Specifications: Properties of the Roxolid® (Ti-13Zr) alloy and other materials.
- Clinical Experience/Predicate Devices: The established safety and effectiveness of the existing Straumann® Bone Level Tapered Implants and reference devices.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML 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.