(54 days)
Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental 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). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
The proposed Straumann Bone Level (BL) Ø4.1 mm and Ø4.8 mm Regular Connection (RC) Roxolid (TiZr) Dental Implants are an extension to the current Bone Level Roxolid implant portfolio. Straumann currently has Bone Level Ø3.3 mm Narrow Connection (NC) Roxolid dental implants with a prosthetic platform of Ø3.3 mm.
The proposed devices are Bone Level (BL) Roxolid dental implants in diameters of 4.1 mm and 4.8 mm. The implants will be available in 4 lengths; 8.0 mm, 10.0 mm, 12.0 mm and 14.0 mm.
The body of the proposed implants has a threaded implant body design made of Straumann's Titanium Zirconium (TiZr) Alloy material with Straumann's SLActive surface treatment currently cleared under K083550. The proposed changes are design changes only. There are no changes to the material, surface treatment, indications for use, fundamental operating principles, or sterilization processes or procedures as a result of the proposed design changes. No new surgical instruments are being introduced as placement of the proposed implants will follow the established surgical protocols of the currently cleared Straumann Dental Implant Systems.
The Straumann Bone Level Ø4.1mm and Ø4.8mm RC Roxolid Implants are dental implants used for oral endosteal implantation. The performance testing was conducted to ensure the device's intended function and that its design input matches the design output.
Here's an analysis of the acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue Testing: In accordance with ISO 14801:2007(E), Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. | The manufacturer states: "The results from the testing conducted demonstrated that the Straumann Bone Level (BL) Ø4.1 mm and Ø4.8 mm Regular Connection (RC) Roxolid Dental Implants function as intended and met the pre-determined acceptance criteria." While specific numerical performance values are not given, the claim is that the device met the criteria of this standard, implying sufficient fatigue resistance. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the fatigue testing. The testing type, "Performance Testing," under "Fatique Testing in accordance to ISO 14801:2007(E)," typically involves a controlled laboratory environment using physical samples of the device.
- Sample Size: Not explicitly stated.
- Data Provenance: The testing was conducted by Straumann itself as part of their verification and validation process. This is laboratory bench testing, not clinical data from patients. Therefore, terms like "country of origin" or "retrospective/prospective" are not applicable in the human data sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable. The "ground truth" for this type of device (dental implant mechanical performance) is established by adherence to a recognized international standard (ISO 14801:2007) and engineering principles, rather than expert clinical consensus. The standard itself defines the methodology and acceptance criteria.
4. Adjudication Method for the Test Set:
This information is not applicable as the "test set" refers to physical devices undergoing mechanical testing, not clinical cases requiring expert adjudication. The compliance with the ISO standard serves as the "adjudication."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This submission focuses on the mechanical performance and substantial equivalence of new implant diameters to existing cleared devices, primarily through bench testing. It does not involve human readers evaluating clinical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
This is not applicable. The device is a physical dental implant, not an AI algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here.
7. The Type of Ground Truth Used:
The ground truth used for this performance testing is compliance with international standards (ISO 14801:2007(E)) for dynamic fatigue testing of endosseous dental implants. This standard sets the scientific and engineering benchmarks for evaluating a device's mechanical integrity under simulated physiological conditions.
8. The Sample Size for the Training Set:
This is not applicable. As the device is a physical dental implant and not an AI or software device, there is no "training set." The development would involve engineering design, finite element analysis (FEA), and physical prototyping/testing, but not a data training set in the machine learning sense.
9. How the Ground Truth for the Training Set was Established:
This is not applicable as there is no "training set" for this type of device. The design and manufacturing processes are validated through engineering principles and compliance with quality management systems.
§ 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.