Stainless Steel Bracket

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 002-0073HDLLWF

by American Orthodontics

Identity

Trade Name: Stainless Steel Bracket EUDAMED
Stainless Steel Brackets FDA UDI
Generic Name: Orthodontic bracket, metal FDA UDI
Device Name: Stainless Steel Bracket EUDAMED
WELD BKT SS LL 1ST BIC 022 T-17 A=0 R4D W/HK DIST INTER HGW FDA UDI
Model / Reference: 002-0073HDLLWF EUDAMEDFDA UDI
Description: WELD BKT SS LL 1ST BIC 022 T-17 A=0 R4D W/HK DIST INTER HGW FDA UDI

Identifiers

Catalog Number: 002-0073HDLLWF FDA UDI
Primary DI / UDI-DI: 00190746141287 EUDAMEDFDA UDI
Basic UDI-DI: 01907460000143DR EUDAMED
FDA Product Code: EJF FDA UDI
EMDN Code: Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
GMDN Term: Orthodontic bracket, metal FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 872.5410 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Orthodontic tube

Stainless Steel Bracket by American Orthodontics — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthodontic tube.

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	01907460000143DR	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: American Orthodontics
EUDAMED SRN: US-MF-000007702
Authorised Representative: Medical Technology Promedt Consulting GmbH DE-AR-000000085

Sources (2)

EUDAMED ce72f86d-ddc5-4ff9-b86c-3024f22292f4 61 fields · synced Jun 9, 2026
FDA UDI c1325112-9c78-43d2-aaf8-d02361e08f08 36 fields · synced May 30, 2026