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PlasmaCure BXE

by Eele Laboratories, LLC

510(k) K033795

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 NumberK033795 Date19 Dec 2003ClearedStatusActive

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  • Withdrawn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
EBZ
Device Class
Class II
Regulation
21 CFR Part 872.6070
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

The PlasmaCure BXE is an Activator, Ultraviolet, For Polymerization device used in dental applications. It is a Class II medical device that received FDA 510(k) clearance as substantially equivalent to predicate devices.

The device is supplied by Eele Laboratories, LLC and is identified by the product code EBZ and regulation number 872.6070. It was cleared through the traditional 510(k) pathway with decision date December 19, 2003, and is intended for use in dental settings for polymerization activation via ultraviolet light.

Questions

AI-generated answers, 24 Sep 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 PlasmaCure BXE used for in dental settings?

    The PlasmaCure BXE is an activator that uses ultraviolet light to initiate polymerization in dental materials, enabling the curing of light-curable resins and composites during restorative procedures.

  • How is the PlasmaCure BXE supplied and identified by the manufacturer?

    The PlasmaCure BXE is supplied by Eele Laboratories, LLC and is identified by the product code EBZ and regulation number 872.6070, which are used for regulatory tracking and device classification.

  • Is the PlasmaCure BXE a single-use or reusable device, and what is its regulatory pathway?

    The PlasmaCure BXE is a reusable device that received FDA 510(k) clearance through the traditional pathway, demonstrating substantial equivalence to a predicate device, and is classified as a Class II medical device.