EdgeFile® X74004BCGP

by US Endodontics, LLC.

EdgeFile® X74004BCGP is a Class I device made by US Endodontics, LLC., listed in FDA GUDID since 25 Jun 2023 (UDI-DI 00818365020812), 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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00818365020812 UDI-DI	Date25 Jun 2023Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00818365020812

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: EdgeFile®
Generic name: Synthetic gutta-percha
Model / Ref / Catalog: X74004BCGP

Primary DI / UDI-DI: 00818365020812
FDA product code: EKM
GMDN term: Synthetic gutta-percha

Device class: Class I
Regulation number: 872.3850
GUDID distribution status: In Commercial Distribution

Similar devices

Other devices filed under FDA product code EKM (GUTTA-PERCHA).

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Properties

Single use
Prescription use
Premarket exempt
Lot / batch number
Expiration date

Other properties (10, all answered No)