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Superelastic Titanium Memory

FDA UDI

Class I (US FDA UDI)

by American Orthodontics

Identity

Trade Name
Superelastic Titanium Memory FDA UDI
Generic Name
Orthodontic wire FDA UDI
Device Name
WIRE NITI FORM I UPPER 018X025 T=20 38MM IND 10/PK FDA UDI
Model / Reference
857-54238TQSPW FDA UDI
Description
WIRE NITI FORM I UPPER 018X025 T=20 38MM IND 10/PK FDA UDI

Identifiers

Catalog Number
857-54238TQSPW FDA UDI
Primary DI / UDI-DI
00190746150036 FDA UDI
FDA Product Code
DZC FDA UDI
GMDN Term
Orthodontic wire FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5410 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Orthodontic wire

Superelastic Titanium Memory by American Orthodontics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic wire.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American Orthodontics

Sources (1)

  • FDA UDI 595d0214-84d0-4d6a-ae6a-95b91a6ad829 36 fields · synced Jun 9, 2026