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Device Explorer · FDA GUDID · GMDN 16367

Dental amalgam

A dental restorative material used primarily to fill tooth cavities, prepared by mixing liquid mercury (Hg) with an alloy of fine particles, composed mainly of silver (Ag), tin (Sn) and copper (Cu). The amalgam may be in either powder or tablet form, or in cap

US‑registered devices366in commercial distribution
Companies12labelers on GUDID
Single‑use99%of device records
Sterile1%labelled sterile
Prescription44%Rx‑only share
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Share of device records

Silmet Ltd9225%
Wykle Research, Inc7621%
Dmg America, Llc7220%
Henry Schein, Inc.4412%
Darby Dental Supply, Llc308%
Ivoclar Vivadent, Inc.185%
Dental Health Products Inc144%
3D Dental Designs And Development, Llc62%

Top labelers

CompanyDevicesShare
Silmet Ltd9225%
Wykle Research, Inc7621%
Dmg America, Llc7220%
Henry Schein, Inc.4412%
Darby Dental Supply, Llc308%
Ivoclar Vivadent, Inc.185%
Dental Health Products Inc144%
3D Dental Designs And Development, Llc62%
National Distribution & Contracting, Inc.51%
Safco Dental Supply Co.51%
Jeremiah Waldon Sales Professional, Inc.31%
Aesculap, Inc.10%

Company = labeler of record on GUDID. 12 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Spherodon M EconomSpherodon MSpherodon +ProSilverNogamaProCopperSpherodon +Spherodon - MSpherodon - M EconomAESCULAPJBrandANA 2000 Capsules 2 Spill 50 countANA 2000 Capsules 1 Spill 50 countOriginal D Powder Ex Fast Set 5 ozOriginal D Powder Ex Fast Set 10 ozOriginal D Ex Fast Jar

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
EJJAlloy, Amalgam238
EJJAlloy, amalgam102
OIVDental Amalgam45
EKICARRIER, AMALGAM, OPERATIVE1

GMDN & GCC registration

  • GMDN code 16367 · non‑implantable
  • Single‑use 99% · sterile 1% · Rx‑only 44% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Milligram) · 172Weight (Gram) · 6

Use these as the dimensions to specify in a tender line.

How many dental amalgam products are registered in the US?

366 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental amalgam", from 12 companies. The largest labeler is Silmet Ltd with 25% of records.

Which FDA product codes apply?

EJJ (Alloy, Amalgam), EJJ (Alloy, amalgam), OIV (Dental Amalgam), EKI (CARRIER, AMALGAM, OPERATIVE)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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