Consulting Wallah › Device Explorer › Other devices › Manual endodontic filling material spreader
Device Explorer · FDA GUDID · GMDN 37678

Manual endodontic filling material spreader

A hand-held, manually-operated dental instrument specifically designed to compress filling materials in a root canal, mainly in a lateral direction. The working part is tapered, circular in cross-section and has a pointed tip. This is a reusable device.

US‑registered devices281in commercial distribution
Companies25labelers on GUDID
Single‑use3%of device records
Sterile1%labelled sterile
Prescription39%Rx‑only share
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Share of device records

Diadent Group International6423%
Hu-Friedy Mfg. Co., Llc5219%
Nordent Manufacturing Inc4416%
Mani, Inc.155%
Premier Dental Products Company145%
Fkg Dentaire Sàrl145%
A. Titan Instruments, Inc.135%
Henry Schein, Inc.135%

Top labelers

CompanyDevicesShare
Diadent Group International6423%
Hu-Friedy Mfg. Co., Llc5219%
Nordent Manufacturing Inc4416%
Mani, Inc.155%
Premier Dental Products Company145%
Fkg Dentaire Sàrl145%
A. Titan Instruments, Inc.135%
Henry Schein, Inc.135%
American Medicals83%
Darby Dental Supply, Llc62%
Essential Dental Systems, Inc.62%
J & J Instruments Inc52%

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

Brand names on the register (sample)

DencoMANI SPREADERSDarby Dental Supply, LLCSPREADERBrasseler USADental Engineering Lab-TFRKA. Titan InstrumentsAmerican Eagle InstrumentsJMUZOLL-DENTALNORDENT MANUFACTURING INC.BLUE AND GREENBRASSELER USANORDENT MANUFACTURING INCBURKHART DENTALJ & J INSTRUMENTS

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

FDA product codes

CodeNameDevices
EKKSpreader, Pulp Canal Filling Material, Endodontic157
EKKSPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC121
DZNInstruments, Dental Hand15
EKQPREPARER, ROOT CANAL ENDODONTIC6
DZADRILL, DENTAL, INTRAORAL6
EKQPreparer, Root Canal Endodontic5

GMDN & GCC registration

  • GMDN code 37678 · non‑implantable
  • Single‑use 3% · sterile 1% · Rx‑only 39% · 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

Length (Inch) · 1

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

How many manual endodontic filling material spreader products are registered in the US?

281 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Manual endodontic filling material spreader", from 25 companies. The largest labeler is Diadent Group International with 23% of records.

Which FDA product codes apply?

EKK (Spreader, Pulp Canal Filling Material, Endodontic), EKK (SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC), DZN (Instruments, Dental Hand), EKQ (PREPARER, ROOT CANAL ENDODONTIC)

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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