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Device Explorer · FDA GUDID · GMDN 62725

Dental delivery system instrument unit, pneumatic

A pneumatically-powered device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, sca

US‑registered devices360in commercial distribution
Companies11labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription4%Rx‑only share
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Share of device records

Dci International, Llc33392%
Vector R&D, Inc.103%
Ultradent Products, Inc.41%
Flight Dental Systems31%
Flight Dental Systems Usa Inc.31%
Safco Dental Supply Co.21%
Biotec Incorporated10%
Anodia Systems10%

Top labelers

CompanyDevicesShare
Dci International, Llc33392%
Vector R&D, Inc.103%
Ultradent Products, Inc.41%
Flight Dental Systems31%
Flight Dental Systems Usa Inc.31%
Safco Dental Supply Co.21%
Biotec Incorporated10%
Anodia Systems10%
Proma, Inc.10%
Dome, Inc.10%
W & H Dentalwerk Bürmoos Gmbh10%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ultrapro Tx airBiotecFlight Dental SystemsZoralVector R&D, IncSafco Incite Slow Speed Handpiece SetDCI EdgeDCI PartsDCIPromaDOME Coronado Dental Delivery UnitAC-1.0 Advanced Air

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

FDA product codes

CodeNameDevices
EIAUnit, Operative Dental387
EFBHandpiece, air-powered, dental18
EGSHandpiece, contra- and right-angle attachment, dental2
EFBHandpiece, Air-Powered, Dental2
NRDUnit, Operative Dental, Accessories1

GMDN & GCC registration

  • GMDN code 62725 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 4% · 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

Height (Inch) · 1

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

How many dental delivery system instrument unit, pneumatic products are registered in the US?

360 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental delivery system instrument unit, pneumatic", from 11 companies. The largest labeler is Dci International, Llc with 92% of records.

Which FDA product codes apply?

EIA (Unit, Operative Dental), EFB (Handpiece, air-powered, dental), EGS (Handpiece, contra- and right-angle attachment, dental), 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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