EUDAMED device

Metal Brackets

EUDAMED device 00192029045428 · TP Orthodontics, Inc.

Key facts

Primary DI 00192029045428
Device name Metal Brackets
Reference or catalog number 293-0101
Manufacturer TP Orthodontics, Inc.
Manufacturer SRN US-MF-000020559
Risk class Class IIa
EMDN code Q010403
EMDN description ORTHODONTIC BRACKETS AND BUTTONS
Legislation mdr
Implantable No
Sterile No
Single use Yes
Status date Jun 11, 2025

At a glance

  • Yes Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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