Consulting Wallah › Device Explorer › Other devices › Endodontic enlarger, single-use
Device Explorer · FDA GUDID · GMDN 63721

Endodontic enlarger, single-use

A non-sterile manual dental instrument designed to be used to access the root canal and to enlarge the opening of the coronal portion of the root canal. This is a single-use device.

US‑registered devices149in commercial distribution
Companies2labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Icp, Inc.13591%
The Atlanta Dental Supply Company149%

Top labelers

CompanyDevicesShare
Icp, Inc.13591%
The Atlanta Dental Supply Company149%

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

Brand names on the register (sample)

Dental CityAdvance Dental Products

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

FDA product codes

CodeNameDevices
EKQPreparer, Root Canal Endodontic135
DZADRILL, DENTAL, INTRAORAL14

GMDN & GCC registration

  • GMDN code 63721 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 0% · OTC 91%
  • 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 endodontic enlarger, single-use products are registered in the US?

149 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endodontic enlarger, single-use", from 2 companies. The largest labeler is Icp, Inc. with 91% of records.

Which FDA product codes apply?

EKQ (Preparer, Root Canal Endodontic), DZA (DRILL, DENTAL, INTRAORAL)

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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