Consulting Wallah › Device Explorer › Dental › Dental power tool system handpiece, remotely-drive
Device Explorer · FDA GUDID · GMDN 38611

Dental power tool system handpiece, remotely-driven

A hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device does not incorporate a power source (e.g., an

US‑registered devices50in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription62%Rx‑only share
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Share of device records

Guilin Woodpecker Medical Instrument Co., Ltd.2448%
Osada Electric Co.,Ltd.1938%
Henry Schein, Inc.48%
Bicon, Llc24%
Nouvag Ag12%

Top labelers

CompanyDevicesShare
Guilin Woodpecker Medical Instrument Co., Ltd.2448%
Osada Electric Co.,Ltd.1938%
Henry Schein, Inc.48%
Bicon, Llc24%
Nouvag Ag12%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PacDentMedidentaDTEWOODPECKERSH42SH29SSH29S/LVS/MCS8 assy.SH28S/LVS/MCC6 assy.SH28SSH28CH21B contra headSH27CS032 contra shankCS031 contra shankCS132 contra shankCH09 contra head

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

FDA product codes

CodeNameDevices
EKXHandpiece, Direct Drive, Ac-Powered25
EKXHANDPIECE, DIRECT DRIVE, AC-POWERED20
EFBHandpiece, air-powered, dental4
EGSHandpiece, Contra- And Right-Angle Attachment, Dental3

GMDN & GCC registration

  • GMDN code 38611 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 62% · OTC 38%
  • 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.

How many dental power tool system handpiece, remotely-driven products are registered in the US?

50 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental power tool system handpiece, remotely-driven", from 5 companies. The largest labeler is Guilin Woodpecker Medical Instrument Co., Ltd. with 48% of records.

Which FDA product codes apply?

EKX (Handpiece, Direct Drive, Ac-Powered), EKX (HANDPIECE, DIRECT DRIVE, AC-POWERED), EFB (Handpiece, air-powered, dental), EGS (Handpiece, Contra- And Right-Angle Attachment, Dental)

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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