FDA Device Intelligence
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Tube, Orthodontic

FDA product code DZD · Class 1 · Dental

12,858
Registered devices
26
Adverse events
4
Recalls
8
510(k) clearances

Devices with this code

3M™ Unitek™ Victory Series™ MBT™ — 3M UNITEK CORPORATIONN.A. — Forestadent Bernhard Förster GmbHN.A. — Forestadent Bernhard Förster GmbHTruEase — ORTHO TECHNOLOGY, INC.NA — G & H Wire Company, Inc.NA — G & H Wire Company, Inc.Generic Buccal Tubes — AMERICAN ORTHODONTICS CORPORATIONTruFit™ — Ortho Organizers, Inc.Elite® — Ortho Organizers, Inc.ifit — AMERICAN ORTHODONTICS CORPORATIONN.A. — Forestadent Bernhard Förster GmbHRMO — Rmo, Inc.N.A. — Forestadent Bernhard Förster GmbHLEONE SPA — LEONE SPARMO — Rmo, Inc.ORJ — Fortune Worldwide LLCLEONE SPA — LEONE SPAN.A. — DENTAURUM GmbH & Co.KGEmpower SL Molar — AMERICAN ORTHODONTICS CORPORATIONGeneric Buccal Tubes — AMERICAN ORTHODONTICS CORPORATIONNA — G & H Wire Company, Inc.RMO — Rmo, Inc.LEONE SPA — LEONE SPAN.A. — Forestadent Bernhard Förster GmbH

Recent recalls

DateFirmReason
2020-01-17Ormco/SybronendoThe action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure,
2020-01-17Ormco/SybronendoThe action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure,
2013-03-08Ormco/SybronendoOrmco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the Bracket Buccal Tubes pro
2010-11-01Ortho Organizers IncProducts were mis-labeled as nickel free.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.