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Device Explorer · FDA GUDID · GMDN 44908

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

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 the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or

US‑registered devices1,079in commercial distribution
Companies31labelers on GUDID
Single‑use9%of device records
Sterile0%labelled sterile
Prescription70%Rx‑only share
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Share of device records

Satelec12311%
Hu-Friedy Mfg. Co., Llc11911%
E.M.S. Electro Medical Systems S.A.10610%
Guilin Veirun Medical Technology Co., Ltd.989%
Guilin Woodpecker Medical Instrument Co., Ltd.838%
Mectron Spa484%
Nakanishi Inc.474%
Dentsply Professional474%

Top labelers

CompanyDevicesShare
Satelec12311%
Hu-Friedy Mfg. Co., Llc11911%
E.M.S. Electro Medical Systems S.A.10610%
Guilin Veirun Medical Technology Co., Ltd.989%
Guilin Woodpecker Medical Instrument Co., Ltd.838%
Mectron Spa484%
Nakanishi Inc.474%
Dentsply Professional474%
Sirona Dental Systems Gmbh434%
Parkell, Inc.293%
Benco Dental Supply Co.283%
Osada Electric Co.,Ltd.262%

Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Instruments PS MAX PSL PSRInstrument PS MAX x3Instrument PS MAXPIEZONInstruments PSR PSLInstruments PS PSR PSLInstruments A P PSAIR-FLOW-PIEZONPiezonDelsonic Scaler InsertUltrasonic Scaler InsertUltrasonic Scaler TipsWOODPECKERDTEWOODPECKER,DTEPerio Kit A

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

FDA product codes

CodeNameDevices
ELCScaler, Ultrasonic710
ELCScaler, ultrasonic333
EMNScaler, Periodontic137
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE22
NDPAccessories, Implant, Dental, Endosseous15
DZIDrill, Bone, Powered10

GMDN & GCC registration

  • GMDN code 44908 · non‑implantable
  • Single‑use 9% · sterile 0% · Rx‑only 70% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Gram) · 16Length (Inch) · 7Width (Inch) · 7Outer Diameter (Millimeter) · 5Height (Inch) · 1Weight (Pound) · 1

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

How many ultrasonic dental scaling/debridement system handpiece tip, periodontal products are registered in the US?

1,079 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, periodontal", from 31 companies. The largest labeler is Satelec with 11% of records.

Which FDA product codes apply?

ELC (Scaler, Ultrasonic), ELC (Scaler, ultrasonic), EMN (Scaler, Periodontic), MDM (INSTRUMENT, MANUAL, SURGICAL, GENERAL USE)

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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