Consulting Wallah › Device Explorer › Other devices › Gutta-percha injector
Device Explorer · FDA GUDID · GMDN 44859

Gutta-percha injector

A hand-held, pistol-shaped, electrically-heated device used to deliver warmed and softened gutta-percha to the dental root canal. Sticks of gutta-percha are inserted into the device and thermally softened before being squeezed out with the ejection trigger thr

US‑registered devices94in commercial distribution
Companies6labelers on GUDID
Single‑use27%of device records
Sterile0%labelled sterile
Prescription77%Rx‑only share
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Share of device records

Peter Brasseler Holdings, Llc3941%
Guilin Woodpecker Medical Instrument Co., Ltd.2931%
Tulsa Dental Products Llc89%
Maillefer Instruments Holding Sàrl89%
Hsg-S Corp.66%
Denjoy Dental Co.,Ltd44%

Top labelers

CompanyDevicesShare
Peter Brasseler Holdings, Llc3941%
Guilin Woodpecker Medical Instrument Co., Ltd.2931%
Tulsa Dental Products Llc89%
Maillefer Instruments Holding Sàrl89%
Hsg-S Corp.66%
Denjoy Dental Co.,Ltd44%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

JAS Unit Endo System plus JAS Pack Gutta-Percha Gutta Percha CutterGutta percha obturation systemCordless Gutta percha obturation systemEDEGENDODTE,WOODPECKERDBADTEWOODPECKERBrasseler USAEdgeEndoGutta-SmartCalamusGutta Smart

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

FDA product codes

CodeNameDevices
EKRPLUGGER, ROOT CANAL, ENDODONTIC53
EKRPlugger, Root Canal, Endodontic32
EKMGUTTA-PERCHA8
NYDEndodontic Kit1

GMDN & GCC registration

  • GMDN code 44859 · non‑implantable
  • Single‑use 27% · sterile 0% · Rx‑only 77% · 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 gutta-percha injector products are registered in the US?

94 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Gutta-percha injector", from 6 companies. The largest labeler is Peter Brasseler Holdings, Llc with 41% of records.

Which FDA product codes apply?

EKR (PLUGGER, ROOT CANAL, ENDODONTIC), EKR (Plugger, Root Canal, Endodontic), EKM (GUTTA-PERCHA), NYD (Endodontic Kit)

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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