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Noninium®

FDA UDI

Class I (US FDA UDI)

by Dentaurum

Identity

Trade Name
Noninium® FDA UDI
Generic Name
Orthodontic extraoral headgear FDA UDI
Device Name
Noninium® Face Bow medium, nickel free, inner bow ø 1.15 mm FDA UDI
Model / Reference
740-000-00 FDA UDI
Description
Noninium® Face Bow medium, nickel free, inner bow ø 1.15 mm FDA UDI

Identifiers

Primary DI / UDI-DI
J011740000000 FDA UDI
FDA Product Code
KCR FDA UDI
GMDN Term
Orthodontic extraoral headgear FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3220 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthodontic extraoral headgear

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

Similar devices

Also classified as Orthodontic extraoral headgear.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentaurum

Sources (1)

  • FDA UDI 219e3dcb-ac10-4d5d-bb98-9b29ab2056c0 35 fields · synced Jun 1, 2026