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Amalgam Well

by Hu-Friedy Mfg Co., LLC

Amalgam Well is a dental amalgam well (FDA Class I; FDA product code EKI, Carrier, Amalgam, Operative) made by Hu-Friedy Mfg Co., LLC, listed in FDA GUDID since 2 Apr 2024 (UDI-DI 10889950142438), registry data as of 31 May 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 31 May 2026.

Regulatory status

as of registry sync 31 May 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10889950142438 UDI-DI Date2 Apr 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  • Withdrawn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

Generic name
Dental amalgam well
Model / reference
WELL
Primary DI / UDI-DI
10889950142438
FDA product code
EKI
GMDN term
Dental amalgam well
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 amalgam well

Similar devices

Other devices filed under FDA product code EKI (CARRIER, AMALGAM, OPERATIVE).

Other devices from Hu-Friedy Mfg Co., LLC

See all devices from Hu-Friedy Mfg Co., LLC →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)