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Morpheus

by Meibach Tech Ltda

510(k) K082249

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 · Abbreviated NumberK082249 Date31 Dec 2009ClearedStatusActive

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  • Withdrawn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
EJI
Device Class
Class II
Regulation
21 CFR Part 872.6770
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Morpheus is a syringe, cartridge device. It is substantially equivalent and has a clearance type of abbreviated.

The Morpheus is supplied with an FDA 510K authorization. It is classified as a class 2 device with a regulation number of 872.6770 and a product code of EJI. The device is intended for dental use.

Questions

AI-generated answers, 21 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 Morpheus device intended for?

    The Morpheus is intended for dental use, as specified in its device description and regulatory classification under product code EJI and regulation number 872.6770.

  • How is the Morpheus device supplied and authorized?

    The Morpheus is supplied with an FDA 510K authorization, specifically under K082249, and was determined to be substantially equivalent through an abbreviated clearance process.

  • What regulatory classification does the Morpheus device have?

    The Morpheus is classified as a class 2 medical device with product code EJI and regulation number 872.6770, as indicated in its FDA 510K authorization details.