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EZ Connect

by Kerr Dental Materials Center 510(k)

Active United States

510(k) K000346

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000346 Date14 Apr 2000ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
EBG
Device Class
Class II
Regulation
21 CFR Part 872.3770
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 EZ Connect is a dental device classified as a Crown and Bridge, Temporary, Resin (product code EBG). It is designed as a temporary dental restoration material, intended for use in restorative dentistry to provide a provisional crown or bridge while permanent restorations are fabricated. Its composition and application facilitate quick and secure attachment to prepared tooth structures, ensuring stability during the interim period.

Supplied as a reusable system for dental professionals, the EZ Connect is intended for use in clinical settings where temporary restorations are required. The device is not described as sterile or single-use in the submitted data, though standard dental practice dictates aseptic handling. No MRI safety information is provided, and no specific storage conditions are detailed beyond typical dental material storage. The device holds an FDA 510(k) clearance (K000346) under the Dental (DE) Advisory Committee, classified under Class II – Special Controls

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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 EZ Connect used for?

    The EZ Connect is used as a temporary dental restoration material to provide a provisional crown or bridge while permanent restorations are fabricated, ensuring stability during the interim period.

  • Is the EZ Connect supplied sterile?

    The device is not described as sterile in the submitted data, though standard dental practice dictates aseptic handling.

  • Is the EZ Connect reusable?

    Yes, the EZ Connect is supplied as a reusable system for dental professionals, intended for use in clinical settings where temporary restorations are required.

  • What are the storage conditions for the EZ Connect?

    No specific storage conditions are detailed beyond typical dental material storage.