Consulting Wallah › Device Explorer › Dental › Denture cleanser
Device Explorer · FDA GUDID · GMDN 35871

Denture cleanser

An agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intende

US‑registered devices59in commercial distribution
Companies22labelers on GUDID
Single‑use66%of device records
Sterile0%labelled sterile
Prescription10%Rx‑only share
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Share of device records

Medtech Products Inc.1220%
Thermoplastic Comfort Sys610%
Renfert Gmbh58%
Soluria Ii Llc47%
Great Lakes Dental Technologies, Ltd.47%
Cavex Holland B.V.35%
Premier Dental Products Company35%
Henry Schein, Inc.35%

Top labelers

CompanyDevicesShare
Medtech Products Inc.1220%
Thermoplastic Comfort Sys610%
Renfert Gmbh58%
Soluria Ii Llc47%
Great Lakes Dental Technologies, Ltd.47%
Cavex Holland B.V.35%
Premier Dental Products Company35%
Henry Schein, Inc.35%
Kulzer Gmbh35%
Anhui Greenland Biotech Co.,Ltd23%
Dukal Llc23%
New World Imports, Inc.23%

Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Y-KelinMonolith Tatar 'n' Stain RemoverCavex ImpreSafe starterkitCavex ImpreSafe refillsCavex GreenCleanDarby Dental Supply, LLCPlasdentSmilesaverGuard HealthBrightByteOla Fresh Dental Appliance CleanserTCS Fresh Concentrated Dental Appliance CleanerDENTASOAK KIT-NO CUP(3 MONTHS)TRY-ME DENTASOAK KITDENTASOAK (1 MONTH)DENTASOAK KIT (3 MONTHS)

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

FDA product codes

CodeNameDevices
EFTCleanser, Denture, Over The Counter39
EFTCLEANSER, DENTURE, OVER THE COUNTER12
NUXCleanser, Denture, Prescription5
JERCleaner, Denture, Mechanical4
LRJDisinfectant, Medical Devices3
FLGCleaner, ultrasonic, medical instrument3

GMDN & GCC registration

  • GMDN code 35871 · non‑implantable
  • Single‑use 66% · sterile 0% · Rx‑only 10% · OTC 68%
  • 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 (Fluid Ounce) · 3Total Volume (Milliliter) · 2Total Volume (Gallon) · 1Total Volume (Liter) · 1

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

How many denture cleanser products are registered in the US?

59 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Denture cleanser", from 22 companies. The largest labeler is Medtech Products Inc. with 20% of records.

Which FDA product codes apply?

EFT (Cleanser, Denture, Over The Counter), EFT (CLEANSER, DENTURE, OVER THE COUNTER), NUX (Cleanser, Denture, Prescription), JER (Cleaner, Denture, Mechanical)

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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