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Noninium® 520-120-00

by Dentaurum

Noninium® 520-120-00 is a Class I device made by Dentaurum, cleared under FDA 510(k) K935140 on 4 Feb 1994 and listed in FDA GUDID since 4 Sep 2026 (UDI-DI J011520120000), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K935140

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberJ011520120000 UDI-DI Date4 Sep 2026ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK935140 Date4 Feb 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K935140 decided 4 Feb 1994 Active
  • FDA GUDID UDI-DI J011520120000 listed 4 Sep 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K935140
  2. Listed FDA GUDID J011520120000

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Noninium®
Generic name
Orthodontic wire
Model / reference
520-120-00
Primary DI / UDI-DI
J011520120000
510(k) Number
FDA product code
DZC
GMDN term
Orthodontic wire
Device class
Class I
Regulation number
872.5410
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K935140)

and 8 more cleared under K935140

Other devices from Dentaurum

See all devices from Dentaurum →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)