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Device Explorer · FDA GUDID · GMDN 45420

Dental laboratory power tool system

An assembly of devices intended to be used in a dental laboratory to bore/cut/grind dental fixtures, appliances, and materials for their preparation or repair. It typically consists of a drilling handpiece, a compact mains electricity (AC-powered) motor, an en

US‑registered devices51in commercial distribution
Companies6labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription8%Rx‑only share
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Share of device records

Darby Dental Supply, Llc2243%
Coltene/Whaledent Inc1937%
Saeshin Precision Co., Ltd.510%
Young Dental Manufacturing I, Llc36%
Osada Electric Co.,Ltd.12%
Peter Brasseler Holdings, Llc12%

Top labelers

CompanyDevicesShare
Darby Dental Supply, Llc2243%
Coltene/Whaledent Inc1937%
Saeshin Precision Co., Ltd.510%
Young Dental Manufacturing I, Llc36%
Osada Electric Co.,Ltd.12%
Peter Brasseler Holdings, Llc12%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OSADA EXL-M40Darby Dental Supply, LLCBrasseler USAPindexYoungTD-AUTOTRAUS SSG30

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

FDA product codes

CodeNameDevices
EJLBUR, DENTAL22
NDPAccessories, Implant, Dental, Endosseous19
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Acces4
EKXHandpiece, direct drive, ac-powered3
EKXHANDPIECE, DIRECT DRIVE, AC-POWERED1
EFBHandpiece, air-powered, dental1

GMDN & GCC registration

  • GMDN code 45420 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 8% · OTC 80%
  • 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 laboratory power tool system products are registered in the US?

51 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental laboratory power tool system", from 6 companies. The largest labeler is Darby Dental Supply, Llc with 43% of records.

Which FDA product codes apply?

EJL (BUR, DENTAL), NDP (Accessories, Implant, Dental, Endosseous), KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Acces), EKX (Handpiece, direct drive, ac-powered)

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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