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Device Explorer · FDA GUDID · GMDN 36047

Ultrasonic dental scaling/debridement system

An assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces duri

US‑registered devices1,181in commercial distribution
Companies41labelers on GUDID
Single‑use11%of device records
Sterile0%labelled sterile
Prescription66%Rx‑only share
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Share of device records

Guilin Woodpecker Medical Instrument Co., Ltd.18215%
E.M.S. Electro Medical Systems S.A.17215%
Kavo Dental Gmbh14112%
Coltene/Whaledent Inc1099%
Satelec696%
Bonart Co., Ltd.686%
Dentsply Professional565%
Nanning Baolai Medical Instrument Co.,Ltd464%

Top labelers

CompanyDevicesShare
Guilin Woodpecker Medical Instrument Co., Ltd.18215%
E.M.S. Electro Medical Systems S.A.17215%
Kavo Dental Gmbh14112%
Coltene/Whaledent Inc1099%
Satelec696%
Bonart Co., Ltd.686%
Dentsply Professional565%
Nanning Baolai Medical Instrument Co.,Ltd464%
Silfradent Srl464%
Nakanishi Inc.403%
Hsg-S Corp.353%
Dent4You Ag292%

Company = labeler of record on GUDID. 41 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GBT Machine AIRFLOW Prophylaxis MasterPIEZON Handpiece LEDPiezonInstrument PI starter kitPIEZONAIR-FLOW-PIEZONPIZON BUILT-IN KITPIEZON BUILT-IN KITPIEZON BUILT IN KIT LEDPIEZON BUILT-IN KIT LEDPIEZON Handpiece S5JETSONIC 2000M HANDPIECEDelsonic 2000 ScalerEighteethSeaskySkysea

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

FDA product codes

CodeNameDevices
ELCScaler, Ultrasonic886
ELCScaler, ultrasonic376
DZIDrill, Bone, Powered53
KOJAIRBRUSH9
KYXDISPENSER, LIQUID MEDICATION6
ELBScaler, Rotary4

GMDN & GCC registration

  • GMDN code 36047 · non‑implantable
  • Single‑use 11% · sterile 0% · Rx‑only 66% · 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

Weight (Pound) · 3

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

How many ultrasonic dental scaling/debridement system products are registered in the US?

1,181 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", from 41 companies. The largest labeler is Guilin Woodpecker Medical Instrument Co., Ltd. with 15% of records.

Which FDA product codes apply?

ELC (Scaler, Ultrasonic), ELC (Scaler, ultrasonic), DZI (Drill, Bone, Powered), KOJ (AIRBRUSH)

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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