remanium®

FDA UDI

Class I (US FDA UDI)

by Dentaurum

Identity

Trade Name: remanium® FDA UDI
Generic Name: Orthodontic archwire FDA UDI
Device Name: remanium® ideal arches, rectangular Mandibular, 0.55 x 0.70 mm / 21,5 x 28 FDA UDI
Model / Reference: 767-207-00 FDA UDI
Description: remanium® ideal arches, rectangular Mandibular, 0.55 x 0.70 mm / 21,5 x 28 FDA UDI

Identifiers

Primary DI / UDI-DI: J011767207000 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

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

Similar devices

Also classified as Orthodontic archwire.

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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

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Manufacturer

Manufacturer: Dentaurum

Sources (1)

FDA UDI f76453ff-59aa-40b0-91fa-d7cf65134b97 36 fields · synced May 30, 2026