Consulting Wallah › Device Explorer › Dental › Dental amalgam condenser, reusable
Device Explorer · FDA GUDID · GMDN 16460

Dental amalgam condenser, reusable

A hand-held manual dental instrument intended for packing amalgam or direct filling gold (Au). It may be smooth or serrated in design and flat or curved in shape. This is a reusable device.

US‑registered devices381in commercial distribution
Companies23labelers on GUDID
Single‑use4%of device records
Sterile5%labelled sterile
Prescription58%Rx‑only share
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Share of device records

Devemed Gmbh14739%
Nordent Manufacturing Inc11831%
Pomee Corporation185%
Kohler Medizintechnik Gmbh154%
Benco Dental Supply Co.144%
Kls-Martin L.P.123%
Darby Dental Supply, Llc92%
Integra Lifesciences Production Corporation82%

Top labelers

CompanyDevicesShare
Devemed Gmbh14739%
Nordent Manufacturing Inc11831%
Pomee Corporation185%
Kohler Medizintechnik Gmbh154%
Benco Dental Supply Co.144%
Kls-Martin L.P.123%
Darby Dental Supply, Llc92%
Integra Lifesciences Production Corporation82%
Karl Schumacher Dental, Llc62%
Pdt, Inc.62%
Young Innovations, Inc.41%
Meta Systems Co., Ltd.41%

Company = labeler of record on GUDID. 23 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

KOHDENTReicodentdevemedDarby Dental Supply, LLCFILLERAMALGAM INSTRUMENTBrasseler USAPaul BandittIntrace USABioHorizonsObtura SpartanKarl SchumacherA. Titan InstrumentsIntra-LockNordent Manufacturing, Inc.NORDENT MANUFACTURING INC.

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

FDA product codes

CodeNameDevices
EIYInstrument, Filling, Plastic, Dental162
EKGCondenser, Amalgam And Foil, Operative151
EKGCONDENSER, AMALGAM AND FOIL, OPERATIVE83
DZNINSTRUMENTS, DENTAL HAND47
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL11
NDPAccessories, Implant, Dental, Endosseous5

GMDN & GCC registration

  • GMDN code 16460 · non‑implantable
  • Single‑use 4% · sterile 5% · Rx‑only 58% · OTC 4%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 15

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

How many dental amalgam condenser, reusable products are registered in the US?

381 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental amalgam condenser, reusable", from 23 companies. The largest labeler is Devemed Gmbh with 39% of records.

Which FDA product codes apply?

EIY (Instrument, Filling, Plastic, Dental), EKG (Condenser, Amalgam And Foil, Operative), EKG (CONDENSER, AMALGAM AND FOIL, OPERATIVE), DZN (INSTRUMENTS, DENTAL HAND)

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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