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Device Explorer · FDA GUDID · GMDN 35793

Dental restoration carver, amalgam, reusable

A hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a dou

US‑registered devices754in commercial distribution
Companies25labelers on GUDID
Single‑use12%of device records
Sterile1%labelled sterile
Prescription19%Rx‑only share
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Share of device records

Nordent Manufacturing Inc19326%
Hu-Friedy Mfg. Co., Llc17723%
American Eagle Instruments, Inc.689%
Peter Brasseler Holdings, Llc507%
Devemed Gmbh436%
Zoll-Dental436%
A. Titan Instruments, Inc.385%
Patterson Dental Supply, Inc.243%

Top labelers

CompanyDevicesShare
Nordent Manufacturing Inc19326%
Hu-Friedy Mfg. Co., Llc17723%
American Eagle Instruments, Inc.689%
Peter Brasseler Holdings, Llc507%
Devemed Gmbh436%
Zoll-Dental436%
A. Titan Instruments, Inc.385%
Patterson Dental Supply, Inc.243%
Premier Dental Products Company193%
Pdt, Inc.172%
Wise Linkers, Llc162%
Darby Dental Supply, Llc152%

Company = labeler of record on GUDID. 25 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Composite Ninja Comfort GripClinician's Choice Composite NinjaReicodentdevemedPRODONT-HOLLIGERDarby Dental Supply, LLCBrasseler USAPaul BandittKarl SchumacherA. Titan InstrumentsAmerican Eagle InstrumentsZOLL-DENTALNordent Manufacturing, Inc.NORDENT MANUFACTURING INCBLUE AND GREENTANAKA DENTAL

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

FDA product codes

CodeNameDevices
EKHCARVER, DENTAL AMALGAM, OPERATIVE399
EKHCarver, Dental Amalgam, Operative321
EMOKNIFE, PERIODONTIC31
EIKCARVER, WAX, DENTAL24
EIYInstrument, Filling, Plastic, Dental22
EKPREAMER, PULP CANAL, ENDODONTIC17

GMDN & GCC registration

  • GMDN code 35793 · non‑implantable
  • Single‑use 12% · sterile 1% · Rx‑only 19% · OTC 2%
  • 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) · 14

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

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

754 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental restoration carver, amalgam, reusable", from 25 companies. The largest labeler is Nordent Manufacturing Inc with 26% of records.

Which FDA product codes apply?

EKH (CARVER, DENTAL AMALGAM, OPERATIVE), EKH (Carver, Dental Amalgam, Operative), EMO (KNIFE, PERIODONTIC), EIK (CARVER, WAX, DENTAL)

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.

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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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