Consulting Wallah › Device Explorer › Dental › Dental power tool system handpiece, line-powered
Device Explorer · FDA GUDID · GMDN 38347

Dental power tool system handpiece, line-powered

A hand-held, mains electricity (AC-powered) dental device that includes a chuck or collet for attaching a dental endpiece (e.g., drill bit, bur, reamer, saw blade, polishing disk) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissue

US‑registered devices115in commercial distribution
Companies10labelers on GUDID
Single‑use4%of device records
Sterile5%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Kavo Dental Gmbh7061%
Intra-Lock International, Inc.2421%
Schlumbohm Gmbh & Co. Kg76%
Saeyang Microtech Co.,Ltd33%
Bonart Co., Ltd.22%
Handpiece Parts & Repairs, Inc.22%
Ace Surgical Supply Co., Inc.22%
Henry Schein, Inc.22%

Top labelers

CompanyDevicesShare
Kavo Dental Gmbh7061%
Intra-Lock International, Inc.2421%
Schlumbohm Gmbh & Co. Kg76%
Saeyang Microtech Co.,Ltd33%
Bonart Co., Ltd.22%
Handpiece Parts & Repairs, Inc.22%
Ace Surgical Supply Co., Inc.22%
Henry Schein, Inc.22%
Aseptico, Inc.22%
Osstem Implant Co., Ltd._Gasan Branch11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SURGmatic S15 L ProSURGmatic Head S201 XL ProSURGmatic Head S201 L ProSMARTmatic S53SMARTmatic PROPHY S33SMARTmatic ENDO S321Elements 8:1SMARTmatic ENDO S81SMARTmatic S80 KSMARTmatic S20 SSMARTmatic S20 KSMARTmatic PROPHY S19 KSMARTmatic PROPHY S19SMARTmatic S10 SSMARTmatic S10 KSMARTmatic S10

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

FDA product codes

CodeNameDevices
KMWHANDPIECE, ROTARY BONE CUTTING52
EFBHANDPIECE, AIR-POWERED, DENTAL44
EKXHandpiece, Direct Drive, Ac-Powered27
EFAHandpiece, belt and/or gear driven, dental13
EBWController, Foot, Handpiece And Cord7
EFAHANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL5

GMDN & GCC registration

  • GMDN code 38347 · non‑implantable
  • Single‑use 4% · sterile 5% · Rx‑only 95% · 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) · 2

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

How many dental power tool system handpiece, line-powered products are registered in the US?

115 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental power tool system handpiece, line-powered", from 10 companies. The largest labeler is Kavo Dental Gmbh with 61% of records.

Which FDA product codes apply?

KMW (HANDPIECE, ROTARY BONE CUTTING), EFB (HANDPIECE, AIR-POWERED, DENTAL), EKX (Handpiece, Direct Drive, Ac-Powered), EFA (Handpiece, belt and/or gear driven, 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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