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EdgeGates™ EG0432

by US Endodontics, LLC.

EdgeGates™ EG0432 is a Class I device made by US Endodontics, LLC., listed in FDA GUDID since 25 Jun 2023 (UDI-DI 00818365026173), 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 Number00818365026173 UDI-DI Date25 Jun 2023ListedStatusListed 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  • Withdrawn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
EdgeGates™
Generic name
Manual endodontic file/rasp, single-use
Model / Ref / Catalog
EG0432
Primary DI / UDI-DI
00818365026173
FDA product code
DZA
GMDN term
Manual endodontic file/rasp, single-use
Device class
Class I
Regulation number
872.4130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Manual endodontic file/rasp, single-use

Other devices from US Endodontics, LLC.

See all devices from US Endodontics, LLC. →

Properties

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