(87 days)
LW Pre-milled Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Compatible Implant: LW Implant, LW Narrow Implant
Implant Diameter (mm): 4.2/4.55/4.6/5.0/5.05/5.07/5.4/5.45/5.9/5.95/6.55/6.6/6.8/6.85/7.25/7.3/7.35/7.75/7.8/7.85 (LW Implant), 3.75/3.77 (LW Narrow Implant)
Platform Diameter (mm): 4.2/4.55/4.6/5.0/5.05/5.07/5.4/5.45/5.9/5.95/6.55/6.6/6.8/6.85/7.25/7.3/7.35/7.75/7.8/7.85 (LW Implant), 3.75/3.77 (LW Narrow Implant)
LW Pre-milled Abutment is intended for use with the LW Implant System in the chart. All digitally designed abutments for use with LW Pre-milled Abutment are intended to be manufactured at the OSSVIS-validated milling center.
The LW Pre-milled Abutment is made of Ti-6AI-4V-ELI (ASTM F136), and it is provided non-sterile, which is required to be sterilized by the end-user before use. The subject abutment is indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations.
To produce patient-specific abutments, the cylindrical section of LW Pre-milled Abutment is customized by machining it using CAD/CAM technology. Each patient-specific abutment is custom-prescribed by the clinician.
Abutment Name: LW Pre-milled Abutment, LW Narrow Pre-milled Abutment
Uses: The Abutment is used as a support of prosthesis to restore the patient's chewing function.
Surface Treatment: N/A
Fixture Connection: Hex 2.48 / Non-Hex (LW Pre-milled Abutment), Hex 2.08 / Non-Hex (LW Narrow Pre-milled Abutment)
LW Pre-milled Abutment is compatible with following Implant System.
- LW Pre-milled Abutment
Proprietary Name: LW Implant System
Pre-market Submission Number: K223924
Compatible Implant Device Name: LW Implant
Implant Interface Connection Type/Size (mm): Internal Connection Type/2.5
Type of Implant-Abutment Connection: Hex/Non-Hex
LW Pre-milled Abutment is used with an LW Abutment Screw in LW Implant System(K223924).
- LW Narrow Pre-milled Abutment
Proprietary Name: LW Narrow Implant System
Pre-market Submission Number: K233808
Compatible Implant Device Name: LW Narrow Implant
Implant Interface Connection Type/Size (mm): Internal Connection Type/2.1
Type of Implant-Abutment Connection: Hex/Non-Hex
LW Narrow Pre-milled Abutment is used with an LW Narrow Abutment Screw in LW Narrow Implant System(K233808).
The design envelope for Patient-Specific Abutment are as follows:
Diameter: 4.5-7.0 mm (LW Pre-milled Abutment), 4.0, 4.5 mm (LW Narrow Pre-milled Abutment)
Length: Straight: 7.9 - 16.9 mm, Angled: 12.9, 14.9 mm (LW Pre-milled Abutment)
Minimum gingival height: 1.0 mm (LW Pre-milled Abutment)
Maximum gingival height: 7.0 mm (LW Pre-milled Abutment)
Minimum wall thickness: 0.4 mm (LW Pre-milled Abutment)
Minimum post height for single-unit restorations (length above the abutment collar / gingival height): 4.0 mm (LW Pre-milled Abutment)
Maximum angulation: 30° (LW Pre-milled Abutment)
This FDA 510(k) summary does not contain the information requested regarding acceptance criteria and studies proving the device meets those criteria from an AI/machine learning perspective.
The document describes a dental implant abutment, which is a physical medical device (LW Pre-milled Abutment). The "tests" mentioned are traditional hardware tests for physical devices, not assessments of AI algorithmic performance.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance (for AI): Not applicable. The "device" here is a physical abutment, not an AI model.
- Sample size used for the test set and the data provenance: Not applicable. There is no AI test set.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. There is no AI test set with ground truth.
- Adjudication method for the test set: Not applicable.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone performance (algorithm only) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Instead, the document details non-clinical tests performed on the physical dental abutment, which include:
- End User Sterilization Validation Test (according to ISO 17665-1,-2)
- Fatigue Testing (according to ISO 14801:2016)
- Biocompatibility Testing (according to ISO 10993-1)
- MRI Safety review
These tests are standard for physical medical devices to demonstrate safety and performance under specific conditions, and they are not related to artificial intelligence performance.
§ 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.)