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dx retainer 5 kg 04754

by DETAX GmbH

dx retainer 5 kg 04754 is a Class I device made by DETAX GmbH, listed in FDA GUDID since 6 Mar 2026 (UDI-DI EDET047541), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEDET047541 UDI-DI Date6 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
dx retainer 5 kg
Generic name
Removable dental occlusal splint, custom-made
Model / reference
04754
Primary DI / UDI-DI
EDET047541
FDA product code
DYJ
GMDN term
Removable dental occlusal splint, custom-made
Device class
Class I
Regulation number
872.5410
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Other devices from DETAX GmbH

See all devices from DETAX GmbH →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)