Noninium®

FDA UDI

Class I (US FDA UDI)

by Dentaurum

Identity

Trade Name: Noninium® FDA UDI
Generic Name: Orthodontic archwire FDA UDI
Device Name: Noninium® ideal arches, round Maxillary, 0.35 mm / 14 FDA UDI
Model / Reference: 764-010-00 FDA UDI
Description: Noninium® ideal arches, round Maxillary, 0.35 mm / 14 FDA UDI

Identifiers

Primary DI / UDI-DI: J011764010000 FDA UDI
510(k) Number: K935140 FDA UDI
FDA Product Code: DZC FDA UDI
GMDN Term: Orthodontic archwire 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthodontic archwire

Noninium® by Dentaurum — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic archwire.

NITANIUM® RCS STRAIGHT LEGS — Ortho Organizers, Inc. · Class I
TRUEFORM — G&H Wire Company, Inc. · Class I
3M™ Unitek™ — 3M UNITEK CORPORATION · Class I
EUROPA SOLO-PACK — G&H Wire Company, Inc. · Class I
A.J. WILCOCK® TRUEFORM AUSTRALIAN WIRE SOLO-PACK — G&H Wire Company, Inc. · Class I
Masel — Ortho Organizers, Inc. · Class I
Stainless Steel Archwires — Ortho Organizers, Inc. · Class I
G4 EUROPA NICKEL TITANIUM — G&H Wire Company, Inc. · Class I

Cleared under the same submission

K935140 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Dentaurum

Sources (1)

FDA UDI 37c179f8-4bc2-454e-9be5-1634aa4d3301 36 fields · synced Jun 8, 2026