(150 days)
The LW Retaction Cap is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
The LW Retraction Cap is a component of the LW Implant System (K223924), and it is used with the LW Solid Abutment and LW Vis Abutment of the LW Implant System.
Used to protect the LW Solid Abutment and LW Vis Abutment in the oral cavity.
The LW Retraction Cap is made of POM(Polyoxymethylene(ASTM F1855)) and provided non-sterile, which is required to be sterilized by the end-user before use.
The dimensions of subject device are as following: Ø 5.0, 6.0, 6.1, 6.7, 7.2, 7.7, 8.2, 8.7 mm (D) x 5.5, 7.0, 8.5 mm (L).
The provided text describes the regulatory clearance of a medical device and does not contain information about an AI/ML diagnostic or prognostic device's acceptance criteria or a study proving its performance. The document is a 510(k) premarket notification for a dental device called "LW Retraction Cap," which is an endosseous dental implant abutment.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth and their qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study results
- Standalone (algorithm-only) performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
The document focuses on demonstrating substantial equivalence to a predicate device based on:
- Indications for Use: The LW Retraction Cap is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
- Material: POM (Polyoxymethylene) (ASTM F1855)
- Design Features: Dimensions (various diameters and lengths)
- Sterilization: Provided non-sterile, intended for end-user sterilization.
- Non-Clinical Tests:
- End User Sterilization Validation: Performed according to ISO 17665-1 and ISO 17665-2.
- Biocompatibility Tests: Cytotoxicity Testing performed according to ISO 10993-5 and FDA Guidance.
- Performance Tests: Tests for appearance and dimensions to ensure fit and function.
The conclusion is that the LW Retraction Cap is substantially equivalent to the predicate device because it has the same indication for use, material, design feature, surface treatment, and sterilization. Differences in diameter do not raise serious safety or performance issues as it is used temporarily and fits its compatible abutment.
§ 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.)