Device Explorer · FDA GUDID · GMDN 11168

Dentifrice

A substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or

US‑registered devices824in commercial distribution
Companies56labelers on GUDID
Single‑use76%of device records
Sterile1%labelled sterile
Prescription60%Rx‑only share
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Share of device records

Dentsply International Inc.12115%
Young Dental Manufacturing I, Llc8911%
Preventech587%
Henry Schein, Inc.567%
Keystone Industries486%
Premier Dental Products Company425%
Voco Gmbh273%
Crosstex International, Inc.233%

Top labelers

CompanyDevicesShare
Dentsply International Inc.12115%
Young Dental Manufacturing I, Llc8911%
Preventech587%
Henry Schein, Inc.567%
Keystone Industries486%
Premier Dental Products Company425%
Voco Gmbh273%
Crosstex International, Inc.233%
Safco Dental Supply Co.192%
Kavo Dental Gmbh172%
Ivoclar Vivadent Aktiengesellschaft172%
Cargus International, Inc172%

Company = labeler of record on GUDID. 56 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

REFINEEna ShinyKaVo PROPHYpearls black currantKaVo PROPHYpearls orangeKaVo PROPHYpearls peachKaVo PROPHYpearls mintKaVo PROPHYpearls neutralKaVo PROPHYpearls neutral (4x 1 Fl.)PROPHYflex Perio Powder 20gr.KaVo PROPHYflex Perio Powder (4x Fl.)Prophylaxe Set 2008L/2018 violettProphylaxe Set 2003PROPHYflex powder mailingPROPHYflex powder mintPROPHYflex powder cherryPROPHYflex powder berry

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

FDA product codes

CodeNameDevices
EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY490
EJRAgent, Polishing, Abrasive, Oral Cavity358
LBHVARNISH, CAVITY14
EBFMaterial, Tooth Shade, Resin6
EGSHandpiece, contra- and right-angle attachment, dental5
LBHVarnish, Cavity4

GMDN & GCC registration

  • GMDN code 11168 · non‑implantable
  • Single‑use 76% · sterile 1% · Rx‑only 60% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Gram) · 162Total Volume (Fluid Ounce) · 31Total Volume (Milliliter) · 3Total Volume (Liter) · 1Total Volume (Gallon) · 1

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

No closely related category with 50+ devices.

How many dentifrice products are registered in the US?

824 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dentifrice", from 56 companies. The largest labeler is Dentsply International Inc. with 15% of records.

Which FDA product codes apply?

EJR (AGENT, POLISHING, ABRASIVE, ORAL CAVITY), EJR (Agent, Polishing, Abrasive, Oral Cavity), LBH (VARNISH, CAVITY), EBF (Material, Tooth Shade, Resin)

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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