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Device Explorer · FDA GUDID · GMDN 45572

Dental power tool system, line-powered

An assembly of devices designed to both bore/excavate and saw bones, teeth, and tough tissues during a dental/maxillofacial surgical procedure. It typically consists of a motorized handpiece and/or motor, a control unit, and a variety of attachments used to ho

US‑registered devices93in commercial distribution
Companies3labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription2%Rx‑only share
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Share of device records

Saeshin Precision Co., Ltd.8895%
Osada Electric Co.,Ltd.33%
Bicon, Llc22%

Top labelers

CompanyDevicesShare
Saeshin Precision Co., Ltd.8895%
Osada Electric Co.,Ltd.33%
Bicon, Llc22%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OSADA XL-30WOSADA PEDO-30WOSADA XL-230NATRAUS SIP20TRAUS SUS20TRAUS Dental HandpieceTRAUSX-CUBETRAUS SSG10TRAUS ENDOTRAUS SIP10E-CUBETRAUS SUS10

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

FDA product codes

CodeNameDevices
EBWController, Foot, Handpiece And Cord31
EGSHandpiece, Contra- And Right-Angle Attachment, Dental22
EKXHandpiece, Direct Drive, Ac-Powered14
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Acces14
DZIDrill, Bone, Powered13
EFAHandpiece, Belt And/Or Gear Driven, Dental8

GMDN & GCC registration

  • GMDN code 45572 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 2% · OTC 3%
  • 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, line-powered products are registered in the US?

93 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental power tool system, line-powered", from 3 companies. The largest labeler is Saeshin Precision Co., Ltd. with 95% of records.

Which FDA product codes apply?

EBW (Controller, Foot, Handpiece And Cord), EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), EKX (Handpiece, Direct Drive, Ac-Powered), HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Acces)

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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