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Device Explorer · FDA GUDID · GMDN 47015

Dental ultrasonic surgical system handpiece tip

A removable endpiece intended to be attached to a dental ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to mechanically fragment and cut bone during dental surgery. The device is

US‑registered devices533in commercial distribution
Companies12labelers on GUDID
Single‑use33%of device records
Sterile2%labelled sterile
Prescription76%Rx‑only share
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Share of device records

Mectron Spa15729%
Guilin Woodpecker Medical Instrument Co., Ltd.8115%
Satelec7113%
Nakanishi Inc.6312%
W & H Dentalwerk Bürmoos Gmbh418%
Young Innovations, Inc.387%
Osada Electric Co.,Ltd.336%
E.M.S. Electro Medical Systems S.A.163%

Top labelers

CompanyDevicesShare
Mectron Spa15729%
Guilin Woodpecker Medical Instrument Co., Ltd.8115%
Satelec7113%
Nakanishi Inc.6312%
W & H Dentalwerk Bürmoos Gmbh418%
Young Innovations, Inc.387%
Osada Electric Co.,Ltd.336%
E.M.S. Electro Medical Systems S.A.163%
Vista Dental163%
B& L Biotech, Inc.143%
Power Dental U.S.A. Inc.20%
Gebr. Brasseler Gmbh & Co. Kg10%

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

Brand names on the register (sample)

PIEZONPIEZON MASTER SURGERYWOODPECKERwoodpeckerWOODPECKER,DTEWOODPECKER, DTESG12M-OC1LM-OC1RM-ST1M-RE2ST139ST125Surgical tip set (3)ST108ST107

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

FDA product codes

CodeNameDevices
DZIDrill, Bone, Powered299
ELCScaler, Ultrasonic245
ELCScaler, ultrasonic134
DZIDRILL, BONE, POWERED63
EMKCurette, Surgical, Dental16
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Acces13

GMDN & GCC registration

  • GMDN code 47015 · non‑implantable
  • Single‑use 33% · sterile 2% · Rx‑only 76% · OTC 6%
  • 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 dental ultrasonic surgical system handpiece tip products are registered in the US?

533 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental ultrasonic surgical system handpiece tip", from 12 companies. The largest labeler is Mectron Spa with 29% of records.

Which FDA product codes apply?

DZI (Drill, Bone, Powered), ELC (Scaler, Ultrasonic), ELC (Scaler, ultrasonic), DZI (DRILL, BONE, 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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