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Device Explorer · FDA GUDID · GMDN 44907

Ultrasonic dental scaling/debridement system handpiece

A hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions du

US‑registered devices88in commercial distribution
Companies14labelers on GUDID
Single‑use16%of device records
Sterile0%labelled sterile
Prescription48%Rx‑only share
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Share of device records

Guilin Woodpecker Medical Instrument Co., Ltd.1922%
Satelec1719%
Dentsply Professional1315%
Hu-Friedy Mfg. Co., Llc1112%
Mectron Spa56%
Nakanishi Inc.45%
Parkell, Inc.45%
Osada Electric Co.,Ltd.33%

Top labelers

CompanyDevicesShare
Guilin Woodpecker Medical Instrument Co., Ltd.1922%
Satelec1719%
Dentsply Professional1315%
Hu-Friedy Mfg. Co., Llc1112%
Mectron Spa56%
Nakanishi Inc.45%
Parkell, Inc.45%
Osada Electric Co.,Ltd.33%
Obtura Spartan Endodontics33%
Flight Dental Systems22%
Young Innovations, Inc.22%
Flight Dental Systems Usa Inc.22%

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

Brand names on the register (sample)

WOODPECKERDTEWOODPECKER,DTEOE-11L handpieceSE-03 handpieceSE-15 handpiece / hose assemblyVA2-LUX-HPVA-LUX-HPVA-HPVA2-HPMECTRONACTEONFlight Dental SystemsJohnson-PromidentObtura SpartanProUltra Piezo

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

FDA product codes

CodeNameDevices
ELCScaler, Ultrasonic63
ELCScaler, ultrasonic22
EGSHandpiece, contra- and right-angle attachment, dental8
EKXHandpiece, direct drive, ac-powered5
DZIDrill, Bone, Powered2
EBWController, Foot, Handpiece And Cord1

GMDN & GCC registration

  • GMDN code 44907 · non‑implantable
  • Single‑use 16% · sterile 0% · Rx‑only 48% · 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 ultrasonic dental scaling/debridement system handpiece products are registered in the US?

88 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ultrasonic dental scaling/debridement system handpiece", from 14 companies. The largest labeler is Guilin Woodpecker Medical Instrument Co., Ltd. with 22% of records.

Which FDA product codes apply?

ELC (Scaler, Ultrasonic), ELC (Scaler, ultrasonic), EGS (Handpiece, contra- and right-angle attachment, dental), 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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