LW UCLA Abutment
by Ossvis Co., Ltd. 510(k)
Active
510(k) K231235
Overview
The LW UCLA Abutment is a dental implant abutment classified under the nomenclature code NHA, designed to connect dental implants to prosthetic restorations. It serves as a critical interface for supporting crowns, bridges, or overdentures, ensuring stability and proper alignment in restorative dentistry. Constructed from a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy main body with a polyoxymethylene (POM) plastic sleeve, it is engineered for durability and biocompatibility in oral environments.
This device is intended for use in dental settings and is supplied as a single-use component, adhering to regulatory standards for dental implant systems. It is classified under 21 CFR 872.3630 and holds an FDA 510(k) clearance (K231235) with a decision of Substantially Equivalent (SESE). The abutment is intended for sterile use and must be handled according to dental implant protocols to maintain sterility and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231235 | Date15 Sep 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- NHA
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3630
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Ossvis Co., Ltd.
Questions
What materials is the LW UCLA Abutment made from and why does that matter for dental use?
The LW UCLA Abutment consists of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy main body paired with a polyoxymethylene (POM) plastic sleeve. The Co-Cr-Mo alloy provides exceptional durability and strength, essential for withstanding the mechanical stresses of oral environments, while the POM sleeve enhances biocompatibility and reduces friction between the abutment and prosthetic components. These materials are chosen specifically for their resistance to corrosion, wear, and irritation in the mouth, ensuring long-term stability and patient comfort.
Is the LW UCLA Abutment intended for reuse, or is it designed as a single-use component?
The LW UCLA Abutment is explicitly supplied as a single-use component. This design aligns with standard dental implant protocols to maintain sterility and prevent cross-contamination between patients. Reusing dental implant components can compromise biocompatibility and increase infection risks, so adhering to single-use guidelines is critical for clinical safety and regulatory compliance.
How should I store the LW UCLA Abutment to ensure it remains sterile and functional?
Since the LW UCLA Abutment is intended for sterile use, it must be stored in its original packaging until ready for clinical application. The packaging is designed to preserve sterility, so avoid opening or exposing the device to contaminants. Store it in a clean, dry environment away from direct sunlight or extreme temperatures, as recommended for dental implant components. Always follow the manufacturer’s instructions for storage to maintain its integrity and performance.
What sizes or models of the LW UCLA Abutment are available, and how do I select the right one for a patient?
The LW UCLA Abutment is categorized under the NHA product code, which typically includes variations in diameter, height, and connection type to accommodate different implant platforms and prosthetic needs. While exact sizes aren’t specified in the data, the device is designed to interface with standard dental implants for crowns, bridges, or overdentures. Selection should be based on the patient’s specific implant system, occlusion requirements, and the dentist’s restorative plan—consult the manufacturer’s sizing guides or technical documentation for precise matching.
What regulatory pathway does the LW UCLA Abutment follow, and how does that affect its use in clinical practice?
The LW UCLA Abutment holds an FDA 510(k) clearance (K231235) under the Dental (DE) advisory committee, classified as *Substantially Equivalent (SESE)* to a predicate device. This means it meets FDA standards for safety and effectiveness as determined through a traditional review process. Clinically, this clearance confirms the device adheres to U.S. regulatory requirements for dental implant abutments, ensuring it can be legally marketed and used in dental settings following standard implant protocols. Always verify local regulations if using outside the U.S.