Skip to content

Swede-Vent Endosseous Implant Abutments

by Core-Vent Corp.

510(k) K900182

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK900182 Date9 Nov 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Swede-Vent Endosseous Implant Abutments are dental components designed as abutments for endosseous dental implants. These abutments serve as connectors between the implant fixture placed within the jawbone and the prosthetic crown or dental restoration, facilitating secure attachment and load transfer.

These abutments are supplied as single-use components and are intended for use in dental offices or clinics. They are classified under FDA product code DZE and were granted 510(k) clearance (K900182) in 1990 under the Traditional 510(k) review pathway by the Dental Advisory Committee. No specific sterility or MRI safety information is provided in the available data.

Other devices from Core-Vent Corp.

See all devices from Core-Vent Corp. →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Swede-Vent Endosseous Implant Abutments?

    The Swede-Vent Endosseous Implant Abutments are designed as connectors between the implant fixture embedded in the jawbone and the prosthetic crown or dental restoration. Their role is to ensure a secure attachment, allowing for proper load transfer and stability during chewing or functional use.

  • Are these abutments intended for single-use or reusable applications?

    These abutments are explicitly supplied as single-use components. This classification aligns with dental best practices to minimize cross-contamination risks in clinical settings, ensuring patient safety and sterility.

  • What type of regulatory clearance does the Swede-Vent Endosseous Implant Abutments hold?

    The device was granted FDA 510(k) clearance (K900182) in 1990 under the Traditional 510(k) review pathway by the Dental Advisory Committee. It is classified under FDA product code DZE and was determined to be substantially equivalent to a predicate device.

  • Where are these abutments typically used?

    These abutments are intended for use in dental offices or clinics where endosseous dental implants are placed. They facilitate the final step in restoring dental function by linking the implant fixture to the prosthetic crown.

  • Is there any specific information provided about sterility or MRI safety for these abutments?

    The available data does not include explicit details regarding sterility assurance or MRI safety for the Swede-Vent Endosseous Implant Abutments. Clinicians should follow standard dental protocols for sterilization and verify compatibility with MRI equipment if needed.