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AIGIS-PLUS

by Sb Lucius, Inc.

510(k) K024135

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 NumberK024135 Date10 Mar 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  • Withdrawn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
EJT
Device Class
Class II
Regulation
21 CFR Part 872.3060
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.

AIGIS-PLUS is a gold-based noble metal alloy device classified under product code EJT and regulation number 872.3060 for gold-based alloys and precious metal alloys for clinical use. It is a dental device that received FDA 510(k) clearance as substantially equivalent to a legally marketed device.

The device was manufactured by Sb Lucius, Inc. in Anaheim, California, and received FDA clearance on March 10, 2003, under traditional 510(k) pathway K024135. It is supplied as a finished device for dental clinical use, with no indication of sterility, single-use status, MRI safety, or storage requirements provided in the data.

Other devices from Sb Lucius, Inc.

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    Class II

  • Ceranum 50

    Class II

  • Aigis-Pt

    Class II

  • Aigis-Xo

    Class II

  • Aigis-Super

    Class II

  • Neo 76

    Class II

See all devices from Sb Lucius, Inc. →

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 AIGIS-PLUS device used for?

    The AIGIS-PLUS device is a gold-based noble metal alloy intended for clinical use in dental applications, as indicated by its product code EJT and regulation number 872.3060, which covers precious metal alloys for dental use.

  • Is the AIGIS-PLUS device supplied sterile or non-sterile?

    The device data provides no indication of sterility status for AIGIS-PLUS; it is supplied as a finished device for dental clinical use without any mention of sterilization or sterile packaging.

  • Is the AIGIS-PLUS device intended for single-use or reuse?

    The device data does not specify single-use or reuse status for AIGIS-PLUS; it is described only as a finished device for dental clinical use, with no information provided about disposability or reprocessing requirements.

  • What sizes or models are available for the AIGIS-PLUS device?

    The device data does not list any specific sizes, models, or reference numbers for AIGIS-PLUS beyond the device name itself; no variations or dimensional specifications are provided in the authorization details.

  • How should the AIGIS-PLUS device be stored?

    No storage requirements are indicated in the device data for AIGIS-PLUS; the information provided does not include any guidance on temperature, humidity, or other storage conditions.