(95 days)
Closure Screws, healing caps, and healing abutments, are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Customizable healing abutments made of PEEK are for up to six months.
The Straumann Healing Abutments, Healing Caps, and Closure Screws are intended for use with the Straumann Tissue Level and Bone Level Dental Implant System to protect the inner configuration of the implant and to maintain, stabilize and form the soft tissue during the healing process. The devices are available in various diameters and heights, and the material is Titanium for all Healing Abutments, Healing Caps and Closure Screws; the customizable Healing Abutments are made of polyetheretherketone (PEEK) with a Titanium Alloy inlay.
This is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study with specific acceptance criteria and performance metrics in the way a clinical trial or a novel device submission would. Therefore, much of the requested information about a study proving acceptance criteria is not explicitly provided in this document.
However, I can extract the available information and indicate where specifics are not present.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Validation | All requirements of ISO 11137-1:2006 and ISO 11137-2:2006 for radiation sterilization. | Requirements were met; no deviations. |
| Shelf Life Validation | All requirements of ASTM F1980 for accelerated aging of sterile medical device packages. | Requirements were met; no deviations. |
| Functionality/Performance | Device functions as intended post-modification (sterilization, increased diameter for RC Conical Healing Abutments). | Demonstrated that the devices "function as intended and met the predetermined acceptance criteria." These "predetermined acceptance criteria" are not detailed in the summary. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify a "test set" in the context of a clinical or user study. The testing described (sterilization and shelf life validation) would involve a sample size determined by the respective ISO and ASTM standards, which are not detailed here. The data provenance is internal to Straumann USA, LLC as part of their manufacturing and testing processes. It is not external (e.g., country of origin for clinical data) nor is it described as retrospective or prospective in the context of human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The validation tests performed are for manufacturing and material properties, not clinical ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or assessment of an outcome where adjudication would be necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a submission for a physical medical device (healing abutments, caps, and screws), not a diagnostic or AI-assisted system that would involve human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device does not involve an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the validation tests would be defined by the specifications and measurable outcomes required by the ISO and ASTM standards cited (e.g., sterility levels, package integrity, material properties, functionality). It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. Sample Size for the Training Set
Not applicable. This device does not involve a training set as it is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not involve a training set.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)