Consulting Wallah › Device Explorer › Other devices › Root canal cleaning solution
Device Explorer · FDA GUDID · GMDN 45500

Root canal cleaning solution

A fluid or gel material intended to be used in dentistry to facilitate cleaning/irrigation of the root canal during/after endodontic instrumentation to remove the smear layer, pulpal tissue, necrotic materials, and bacteria from the root canal, before placemen

US‑registered devices84in commercial distribution
Companies19labelers on GUDID
Single‑use42%of device records
Sterile5%labelled sterile
Prescription75%Rx‑only share
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Share of device records

Vista Dental2935%
Tulsa Dental Products Llc1518%
Peter Brasseler Holdings, Llc67%
Henry Schein, Inc.45%
Endo Direct Llc45%
Sonoma Pharmaceuticals, Inc.34%
Essential Dental Systems, Inc.34%
Darby Dental Supply, Llc22%

Top labelers

CompanyDevicesShare
Vista Dental2935%
Tulsa Dental Products Llc1518%
Peter Brasseler Holdings, Llc67%
Henry Schein, Inc.45%
Endo Direct Llc45%
Sonoma Pharmaceuticals, Inc.34%
Essential Dental Systems, Inc.34%
Darby Dental Supply, Llc22%
Jordco Inc22%
Cargus International, Inc22%
Us Endodontics, Llc22%
Nusmile, Ltd.22%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Darby Dental Supply, LLCBrasseler USAEndogelEndocyn Irrigation SolutionEndocyn Root Canal Irrigation SolutionMARK3®MARK3EdgeLube™EdgeGel™Scott's Select RC Cream 2-9gm SyringeHybenX3D DentalAvalon Biomed NeoSolvQ-MixBioPureEDTA Plus

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

FDA product codes

CodeNameDevices
KJJCleanser, Root Canal44
KJJCLEANSER, ROOT CANAL32
EKQPreparer, Root Canal Endodontic5
EKQPREPARER, ROOT CANAL ENDODONTIC3
EICSyringe, Periodontic, Endodontic, Irrigating1

GMDN & GCC registration

  • GMDN code 45500 · non‑implantable
  • Single‑use 42% · sterile 5% · Rx‑only 75% · 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

Total Volume (Milliliter) · 6Total Volume (Fluid Ounce) · 3

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

How many root canal cleaning solution products are registered in the US?

84 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Root canal cleaning solution", from 19 companies. The largest labeler is Vista Dental with 35% of records.

Which FDA product codes apply?

KJJ (Cleanser, Root Canal), KJJ (CLEANSER, ROOT CANAL), EKQ (Preparer, Root Canal Endodontic), 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.

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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