Micro-Vent Endosseous Implant Abutments
510(k) K900181
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK900181 | Date20 Feb 1991 | 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- Withdrawn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, 21 Sep 2026
The Micro-Vent Endosseous Implant Abutments are components designed to attach prosthetic dental devices to endosseous dental implants placed in the jaw bone. They serve as the intermediate connector between the implant fixture and the final prosthesis, providing a stable interface for artificial teeth. The abutments are classified as Class II medical devices and were cleared by the FDA as substantially equivalent to a predicate device.
These abutments are marketed by Core-Vent Corp. of Encino, CA, and were granted FDA 510(k) clearance (K900181) under product code DZE. The clearance was issued on 20 February 1991 following a traditional review by the Dental advisory committee. They are supplied by the manufacturer in accordance with the FDA clearance and are intended for use in dental implant procedures.
Other devices from Core-Vent Corp.
Questions
AI-generated answers, 21 Sep 2026
What clinical purpose do Micro-Vent Endosseous Implant Abutments serve?
They act as the intermediate connector between an endosseous dental implant fixture and the final prosthetic tooth or bridge. By linking the implant to the prosthesis, they create a stable, precise interface that supports artificial teeth and helps distribute occlusal forces to the jawbone, which is essential for long‑term function and patient comfort.
How are the abutments supplied to clinicians?
Core‑Vent Corp. provides the Micro‑Vent abutments directly from its manufacturing facility in Encino, CA. They are shipped in sterile packaging according to the FDA‑cleared specifications, ensuring that each unit arrives ready for immediate use in a dental implant procedure without additional sterilization steps.
Are the Micro‑Vent abutments intended for single‑use or can they be reused?
The device description does not specify reuse, and because they are supplied sterile for immediate clinical application, they are generally considered single‑use items. Re‑sterilizing could compromise the precise tolerances and surface integrity required for a reliable implant‑prosthesis connection.
What sizes or models are available for this implant abutment line?
The provided data list only the product name and does not detail multiple sizes or model variations. Therefore, only the standard Micro‑Vent Endosseous Implant Abutment, as cleared under K900181, is referenced; any additional size options would need to be confirmed with the manufacturer.
What regulatory clearance does this device have?
The abutments received FDA 510(k) clearance (K900181) on 20 February 1991 after a traditional review by the Dental advisory committee. The clearance indicates the device is substantially equivalent to a predicate and is classified as a Class II medical device, allowing it to be marketed for dental implant procedures in the United States.