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EdgeCore for EdgeCoil EC45C

by US Endodontics, LLC.

EdgeCore for EdgeCoil EC45C is a Class I device made by US Endodontics, LLC., listed in FDA GUDID since 25 Apr 2023 (UDI-DI 00819514026273), 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 Number00819514026273 UDI-DI Date25 Apr 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  • Withdrawn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
EdgeCore for EdgeCoil
Generic name
Warm-bonded endodontic obturation system obturator
Model / Ref / Catalog
EC45C
Primary DI / UDI-DI
00819514026273
FDA product code
EKM
GMDN term
Warm-bonded endodontic obturation system obturator
Device class
Class I
Regulation number
872.3850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Warm-bonded endodontic obturation system obturator

Similar devices

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

Other devices from US Endodontics, LLC.

See all devices from US Endodontics, LLC. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)