Consulting Wallah › Device Explorer › Dental › Pneumatic dental scaling/debridement system handpi
Device Explorer · FDA GUDID · GMDN 44909

Pneumatic dental scaling/debridement system handpiece

A holder for a detachable tip that functions as part of a pneumatic dental scaling/debridement system, designed to use compressed air to generate a vibrating action at the tip to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal duri

US‑registered devices65in commercial distribution
Companies4labelers on GUDID
Single‑use5%of device records
Sterile0%labelled sterile
Prescription42%Rx‑only share
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Share of device records

Young Innovations, Inc.3858%
Young Dental Manufacturing I, Llc2132%
J.Morita Mfg.Corp.35%
Scott'S Dental Supply L.L.C.35%

Top labelers

CompanyDevicesShare
Young Innovations, Inc.3858%
Young Dental Manufacturing I, Llc2132%
J.Morita Mfg.Corp.35%
Scott'S Dental Supply L.L.C.35%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AIR SOLFYJohnson-PromidentSCOTT'S SELECT DELUXE SONIC SCALER 4-LINEHygiene DirectDenticatorYoungAthena Champion

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, Dental68
EFBHandpiece, air-powered, dental60
ELCScaler, ultrasonic29
EFBHANDPIECE, AIR-POWERED, DENTAL12
EGSHANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL12
EKXHandpiece, direct drive, ac-powered1

GMDN & GCC registration

  • GMDN code 44909 · non‑implantable
  • Single‑use 5% · sterile 0% · Rx‑only 42% · 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) · 29

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

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

65 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pneumatic dental scaling/debridement system handpiece", from 4 companies. The largest labeler is Young Innovations, Inc. with 58% of records.

Which FDA product codes apply?

EFB (Handpiece, Air-Powered, Dental), EFB (Handpiece, air-powered, dental), ELC (Scaler, ultrasonic), EFB (HANDPIECE, AIR-POWERED, 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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