Skip to content

Auradonics 500-004

by Auradonics Inc.

Auradonics 500-004 is a Class I device made by Auradonics Inc., listed in FDA GUDID since 30 Dec 2019 (UDI-DI 00810033832116), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810033832116 UDI-DI Date30 Dec 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Auradonics
Generic name
Orthodontic separator
Model / reference
500-004
Primary DI / UDI-DI
00810033832116
FDA product code
ECI
GMDN term
Orthodontic separator
Device class
Class I
Regulation number
872.5410
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic separator

Similar devices

Other devices filed under FDA product code ECI (Band, Elastic, Orthodontic).

Other devices from Auradonics Inc.

See all devices from Auradonics Inc. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)