Consulting Wallah › Device Explorer › Dental › Dental-professional prophylaxis brush, single-use
Device Explorer · FDA GUDID · GMDN 64015

Dental-professional prophylaxis brush, single-use

A non-sterile rotary dental instrument with natural or synthetic bristle brushes intended to be used by a dental hygienist and/or dentist to clean and polish teeth. It is designed to be attached to a powered dental handpiece which provides the necessary rotati

US‑registered devices112in commercial distribution
Companies14labelers on GUDID
Single‑use80%of device records
Sterile0%labelled sterile
Prescription32%Rx‑only share
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Share of device records

Edenta Etablissement2119%
Tdv Dental Ltda2119%
Diadent Group International1816%
Young Dental Manufacturing I, Llc1513%
Jmu Dental, Inc1312%
Busch & Co. Gmbh & Co. Kg98%
Hager Worldwide, Inc.44%
Preventech33%

Top labelers

CompanyDevicesShare
Edenta Etablissement2119%
Tdv Dental Ltda2119%
Diadent Group International1816%
Young Dental Manufacturing I, Llc1513%
Jmu Dental, Inc1312%
Busch & Co. Gmbh & Co. Kg98%
Hager Worldwide, Inc.44%
Preventech33%
Gebr. Brasseler Gmbh & Co. Kg22%
Dentamerica, Inc.22%
Mediwish Co.,Ltd11%
Crosstex International, Inc.11%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MediwishEDENTAKOMET Abrasive InstrumentsDENTAMERICABUSCH®, BNA®JMUHager Prophy Brush Regular FlatHager Prophy Brush Fine FlatHager Prophy Angle - Soft CupHager Prophy Angle - Regular CupESA ST Disposable Prophy Angle Taper Brush Box 1ESA MW Disposable Prophy Angle Taper Brush Box 1PIVOT Non-Latex Disposable Prophy Angle Taper BrDenticatorYoungTwist™ Disposable Prophy Angles Brush

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

FDA product codes

CodeNameDevices
EHKCup, Prophylaxis58
EJQWHEEL, POLISHING AGENT21
EHKCUP, PROPHYLAXIS17
EHLPOINT, ABRASIVE12
EGSHandpiece, Contra- And Right-Angle Attachment, Dental2
EFAHandpiece, belt and/or gear driven, dental2

GMDN & GCC registration

  • GMDN code 64015 · non‑implantable
  • Single‑use 80% · sterile 0% · Rx‑only 32% · 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.

No closely related category with 50+ devices.

How many dental-professional prophylaxis brush, single-use products are registered in the US?

112 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental-professional prophylaxis brush, single-use", from 14 companies. The largest labeler is Edenta Etablissement with 19% of records.

Which FDA product codes apply?

EHK (Cup, Prophylaxis), EJQ (WHEEL, POLISHING AGENT), EHK (CUP, PROPHYLAXIS), EHL (POINT, ABRASIVE)

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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