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Device Explorer · FDA GUDID · GMDN 45247

Endodontic obturation system

An assembly of devices intended to be used during endodontic treatment involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimul

US‑registered devices184in commercial distribution
Companies16labelers on GUDID
Single‑use24%of device records
Sterile8%labelled sterile
Prescription49%Rx‑only share
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Share of device records

B& L Biotech, Inc.7842%
Diadent Group International5128%
Meta Systems Co., Ltd.2011%
Young Innovations, Inc.63%
Schlumbohm Gmbh & Co. Kg53%
Changzhou Sifary Medical Technology Co., Ltd.42%
Foshan Coxo Medical Instrument Co.,Ltd.42%
Denjoy Dental Co.,Ltd32%

Top labelers

CompanyDevicesShare
B& L Biotech, Inc.7842%
Diadent Group International5128%
Meta Systems Co., Ltd.2011%
Young Innovations, Inc.63%
Schlumbohm Gmbh & Co. Kg53%
Changzhou Sifary Medical Technology Co., Ltd.42%
Foshan Coxo Medical Instrument Co.,Ltd.42%
Denjoy Dental Co.,Ltd32%
Guilin Refine Medical Instrument Co.,Ltd.21%
Peter Brasseler Holdings, Llc21%
Aseptico, Inc.21%
Maillefer Instruments Holding Sàrl21%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

JAS Unit Endo SystemIntegrated Endo SystemEighteethCOXOREFINEZarcAPOZAEndoPilot² expansion DownPack²EndoPilot D-Pack² handpieceEndoPilot DownPack expansion setEndoPilot Obtura setEndoPilot D-PackSystem B HandpieceBrasseler USAObtura SpartanZ-UP System

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, Endodontic204
EKRPLUGGER, ROOT CANAL, ENDODONTIC7
EATTester, Pulp6
EMNScaler, Periodontic4
EKXHandpiece, Direct Drive, Ac-Powered3
ELCScaler, Ultrasonic3

GMDN & GCC registration

  • GMDN code 45247 · non‑implantable
  • Single‑use 24% · sterile 8% · Rx‑only 49% · 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 endodontic obturation system products are registered in the US?

184 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endodontic obturation system", from 16 companies. The largest labeler is B& L Biotech, Inc. with 42% of records.

Which FDA product codes apply?

EKR (Plugger, Root Canal, Endodontic), EKR (PLUGGER, ROOT CANAL, ENDODONTIC), EAT (Tester, Pulp), EMN (Scaler, Periodontic)

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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