Consulting Wallah › Device Explorer › Dental › Ultrasonic dental scaling/debridement system handp
Device Explorer · FDA GUDID · GMDN 46035

Ultrasonic dental scaling/debridement system handpiece tip, endodontic

An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to fragment and dislodge the debris within the dental pulp for removal during an endodontic pro

US‑registered devices682in commercial distribution
Companies24labelers on GUDID
Single‑use44%of device records
Sterile0%labelled sterile
Prescription21%Rx‑only share
ShareLinkedIn

Share of device records

Guilin Woodpecker Medical Instrument Co., Ltd.32247%
Obtura Spartan Endodontics457%
Osada Electric Co.,Ltd.365%
Engineered Endodontics, Llc315%
Nakanishi Inc.294%
Kerr Corporation274%
Mectron Spa244%
Pearson Dental Supplies, Inc.203%

Top labelers

CompanyDevicesShare
Guilin Woodpecker Medical Instrument Co., Ltd.32247%
Obtura Spartan Endodontics457%
Osada Electric Co.,Ltd.365%
Engineered Endodontics, Llc315%
Nakanishi Inc.294%
Kerr Corporation274%
Mectron Spa244%
Pearson Dental Supplies, Inc.203%
Saeshin Precision Co., Ltd.193%
Peter Brasseler Holdings, Llc152%
Vista Dental152%
Mani, Inc.142%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CICADAREFINEWOODPECKERWOODEPCKERWOODPECKER,DTEDTEDiamond file L2Diamond file A1Diamond file A setDiamond file SDiamond file CSC point 4SC point 3SC point 2SC point 1ST12D

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

FDA product codes

CodeNameDevices
ELCScaler, Ultrasonic514
ELCScaler, ultrasonic111
HABSaw, Powered, And Accessories19
EKQPreparer, Root Canal Endodontic15
EKSFILE, PULP CANAL, ENDODONTIC14
JETPick, Massaging8

GMDN & GCC registration

  • GMDN code 46035 · non‑implantable
  • Single‑use 44% · sterile 0% · Rx‑only 21% · OTC 5%
  • 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 tip, endodontic products are registered in the US?

682 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 tip, endodontic", from 24 companies. The largest labeler is Guilin Woodpecker Medical Instrument Co., Ltd. with 47% of records.

Which FDA product codes apply?

ELC (Scaler, Ultrasonic), ELC (Scaler, ultrasonic), HAB (Saw, Powered, And Accessories), EKQ (Preparer, Root Canal Endodontic)

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.

How do I get quotes?

Add ultrasonic dental scaling/debridement system handpiece tip, endodontic to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Ultrasonic dental scaling/debridement system handpiece tip, endodontic

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying ultrasonic dental scaling/debridement system handp for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →