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prime4me® 430-120-41

by Dentaurum

prime4me® 430-120-41 is a Class I device made by Dentaurum, listed in FDA GUDID since 9 Oct 2025 (UDI-DI J011430120410), 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 NumberJ011430120410 UDI-DI Date9 Oct 2025ListedStatusListed 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  • Withdrawn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
prime4me®
Generic name
Orthodontic retainer
Model / reference
430-120-41
Primary DI / UDI-DI
J011430120410
FDA product code
DYJ
GMDN term
Orthodontic retainer
Device class
Class I
Regulation number
872.5410
GUDID distribution status
In Commercial Distribution

Other devices from Dentaurum

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Properties

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