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Osung Mnd 3ELL501

by Osung Mnd Co., Ltd.

Osung Mnd 3ELL501 is a Class I device made by Osung Mnd Co., Ltd., listed in FDA GUDID since 19 Feb 2024 (UDI-DI 08800075613547), 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 Number08800075613547 UDI-DI Date19 Feb 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  • Withdrawn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
Osung Mnd
Generic name
Dental elevator, tooth/root
Model / reference
3ELL501
Primary DI / UDI-DI
08800075613547
FDA product code
EMJ
GMDN term
Dental elevator, tooth/root
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental elevator, tooth/root

Other devices from Osung Mnd Co., Ltd.

See all devices from Osung Mnd Co., Ltd. →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)