Consulting Wallah › Device Explorer › Dental › Dental restoration carver, amalgam, single-use
Device Explorer · FDA GUDID · GMDN 64036

Dental restoration carver, amalgam, single-use

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 devices115in commercial distribution
Companies2labelers on GUDID
Single‑use100%of device records
Sterile1%labelled sterile
Prescription1%Rx‑only share
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Share of device records

Patterson Dental Supply, Inc.11499%
Robinson Healthcare Limited11%

Top labelers

CompanyDevicesShare
Patterson Dental Supply, Inc.11499%
Robinson Healthcare Limited11%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

InstrapacPatterson

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

FDA product codes

CodeNameDevices
EKSFILE, PULP CANAL, ENDODONTIC114
EKHCarver, Dental Amalgam, Operative1

GMDN & GCC registration

  • GMDN code 64036 · non‑implantable
  • Single‑use 100% · sterile 1% · Rx‑only 1% · 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

No structured size data on the register.

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

How many dental restoration carver, amalgam, single-use products are registered in the US?

115 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental restoration carver, amalgam, single-use", from 2 companies. The largest labeler is Patterson Dental Supply, Inc. with 99% of records.

Which FDA product codes apply?

EKS (FILE, PULP CANAL, ENDODONTIC), EKH (Carver, Dental 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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