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MT1

by The Emerging Technologies Group

510(k) K961383

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 NumberK961383 Date25 Sep 1996ClearedStatusActive

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  • Withdrawn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, 22 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 MT1 is a Class 2 dental device with product code DZE. It is manufactured by The Emerging Technologies Group and was cleared through the Traditional 510(k) pathway.

The device is intended for dental use and was reviewed by the FDA Dental advisory committee. It received FDA clearance on September 25, 1996, after a 190-day review cycle. The device is regulated under 21 CFR 872.3640, the FDA dental device regulatory framework.

Other devices from The Emerging Technologies Group

  • Mt-X

    Class II

  • Mt-2A

    Class II

  • MT1A

    Class II

  • Mt-3A

    Class II

  • Kis-III Non-Submerged Implant, Screws and Cylinders

    Class II

  • Mt-2

    Class II