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Needle HSN5020

by B& L Biotech, inc.

Needle HSN5020 is a Class I device made by B& L Biotech, inc., listed in FDA GUDID since 3 Dec 2024 (UDI-DI 08800019102250), 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 Number08800019102250 UDI-DI Date3 Dec 2024ListedStatusListed 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  • Withdrawn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
Needle
Generic name
Endodontic obturation system
Model / reference
HSN5020
Primary DI / UDI-DI
08800019102250
FDA product code
EKR
GMDN term
Endodontic obturation system
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Endodontic obturation system

Similar devices in this category

Other devices filed under Endodontic obturation system.

Other devices from B&L Biotech Co., Ltd.

See all devices from B&L Biotech Co., Ltd. →

Properties

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