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3D Endo HS2125

by 3D Dental Designs and Development, LLC

3D Endo HS2125 is a Class I device made by 3D Dental Designs and Development, LLC, listed in FDA GUDID since 20 Feb 2023 (UDI-DI 00810126500847), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810126500847 UDI-DI Date20 Feb 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  • Withdrawn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
3D Endo
Generic name
Manual endodontic file/rasp, single-use
Model / Ref / Catalog
HS2125
Primary DI / UDI-DI
00810126500847
FDA product code
EKS
GMDN term
Manual endodontic file/rasp, single-use
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution

Related devices

Category: Manual endodontic file/rasp, single-use

Other devices from 3D Dental Designs and Development, LLC

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Properties

  • Single use
  • Premarket exempt
Other properties (13, all answered No)