LW Implant System
510(k) K223924
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223924 | Date8 Aug 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DZE
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The LW Implant System is an endosseous dental implant abutment, designed for use in dental procedures to support prosthetic restorations. It is classified under product code DZE and falls within the dental implant category, intended for integration with bone tissue to provide stable anchorage for crowns, bridges, or other dental prosthetics. This system is engineered to facilitate predictable osseointegration and long-term functionality in oral rehabilitation.
The LW Implant System is supplied as a sterile, single-use device for dental professionals in clinical settings. It is regulated under 21 CFR 872.3630 and has received FDA 510(k) clearance through a Traditional review process, with a decision date of August 8, 2023. The system is intended for use by trained dental practitioners and must be handled according to aseptic protocols to ensure patient safety and device efficacy. No additional regulatory approvals beyond the stated 510(k) clearance are implied.
Other devices from Ossvis Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the LW Implant System used for in dental procedures?
The LW Implant System is an endosseous dental implant abutment intended to integrate with bone tissue, providing stable anchorage for prosthetic restorations such as crowns, bridges, or other dental prosthetics. Its design supports predictable osseointegration, ensuring long-term functionality in oral rehabilitation.
How is the LW Implant System supplied and what are its sterility and usage guidelines?
The LW Implant System is supplied as a sterile, single-use device exclusively for clinical dental settings. Sterility ensures patient safety, and single-use compliance reduces infection risks. It must be handled under aseptic protocols by trained dental practitioners to maintain efficacy and regulatory compliance.
Is the LW Implant System reusable or intended for single-use?
The LW Implant System is explicitly designed for single-use only. This classification aligns with FDA regulations (21 CFR 872.3630) and clinical best practices to minimize contamination risks and ensure consistent performance during dental procedures.
What regulatory approvals does the LW Implant System hold, and how was it reviewed?
The LW Implant System has received FDA 510(k) clearance through a Traditional review process, classified under product code DZE for dental implants. The decision was made by the Dental (DE) Advisory Committee on August 8, 2023, confirming its substantial equivalence to predicate devices.
What are the key specifications or distinguishing features of the LW Implant System?
The system is engineered for endosseous integration, facilitating predictable osseointegration and long-term stability in prosthetic support. It adheres to FDA standards (21 CFR 872.3630) and is supplied sterile and single-use, ensuring clinical reliability for trained dental professionals.