Consulting Wallah › Device Explorer › Dental › Dental surgical power tool motorized handpiece/set
Device Explorer · FDA GUDID · GMDN 66244

Dental surgical power tool motorized handpiece/set, pneumatic

A pneumatically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical proced

US‑registered devices766in commercial distribution
Companies26labelers on GUDID
Single‑use10%of device records
Sterile0%labelled sterile
Prescription87%Rx‑only share
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Share of device records

Lares Research8811%
J.Morita Mfg.Corp.8711%
Nakanishi Inc.8311%
Dentalez, Inc.8111%
Sirona Dental Systems Gmbh7610%
Peter Brasseler Holdings, Llc517%
Henry Schein, Inc.415%
Mdk Co., Ltd.395%

Top labelers

CompanyDevicesShare
Lares Research8811%
J.Morita Mfg.Corp.8711%
Nakanishi Inc.8311%
Dentalez, Inc.8111%
Sirona Dental Systems Gmbh7610%
Peter Brasseler Holdings, Llc517%
Henry Schein, Inc.415%
Mdk Co., Ltd.395%
Dci International, Llc385%
W & H Dentalwerk Bürmoos Gmbh334%
Vector R&D, Inc.274%
Bien-Air Dental Sa192%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Dental Low-Speed Turbine HandpieceDental High-Speed Turbine HandpieceH511LH311LPAX2-SU05Pana-Max2 M4TiZ9-SU05TiZ9-SU03TiZ9-MU03Z990WLZ990KLZ990LZ890WLZ890KLZ890LCleaning Wire

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

FDA product codes

CodeNameDevices
EFBHandpiece, Air-Powered, Dental433
EFBHandpiece, air-powered, dental250
EFAHandpiece, Belt And/Or Gear Driven, Dental87
EGSHandpiece, Contra- And Right-Angle Attachment, Dental63
EGSHandpiece, contra- and right-angle attachment, dental42
ELCScaler, Ultrasonic2

GMDN & GCC registration

  • GMDN code 66244 · non‑implantable
  • Single‑use 10% · sterile 0% · Rx‑only 87% · 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

Length (Inch) · 23

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

How many dental surgical power tool motorized handpiece/set, pneumatic products are registered in the US?

766 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental surgical power tool motorized handpiece/set, pneumatic", from 26 companies. The largest labeler is Lares Research with 11% of records.

Which FDA product codes apply?

EFB (Handpiece, Air-Powered, Dental), EFB (Handpiece, air-powered, dental), EFA (Handpiece, Belt And/Or Gear Driven, 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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