Consulting Wallah › Device Explorer › Dental › Dental delivery system
Device Explorer · FDA GUDID · GMDN 34991

Dental delivery system

A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, ta

US‑registered devices559in commercial distribution
Companies20labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription24%Rx‑only share
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Share of device records

Ls Enterprises, Inc.28551%
A-Dec, Inc.5810%
Takara Belmont Corp.438%
Kavo Dental Gmbh305%
Aseptico, Inc.275%
Cefla Societa' Cooperativa244%
Ergonomic Products, Inc.214%
Sirona Dental Systems Gmbh204%

Top labelers

CompanyDevicesShare
Ls Enterprises, Inc.28551%
A-Dec, Inc.5810%
Takara Belmont Corp.438%
Kavo Dental Gmbh305%
Aseptico, Inc.275%
Cefla Societa' Cooperativa244%
Ergonomic Products, Inc.214%
Sirona Dental Systems Gmbh204%
Guangzhou Ajax Medical Equipment Co., Ltd.102%
Ritter Concept Gmbh92%
Osstem Implant Co.,Ltd.61%
Anodia Systems51%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ADSelements e-motionELECTROmatic T2M-SELECTROmatic TMC-LELECTROmatic TMC-SELECTROmatic TMM-LELECTROmatic TMM-SELECTROmatic TM-LELECTROmatic TM-SELECTROmatic PC-LELECTROmatic PC-SELECTROmatic PM-LELECTROmatic PM-SELECTROmatic C-LELECTROmatic C-SELECTROmatic M-L

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 Dental528
ELCScaler, Ultrasonic24
EBWController, foot, handpiece and cord23
EBWController, Foot, Handpiece And Cord17
EBWCONTROLLER, FOOT, HANDPIECE AND CORD7
ECBUnit, Syringe, Air And/Or Water3

GMDN & GCC registration

  • GMDN code 34991 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 24% · 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

No structured size data on the register.

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

How many dental delivery system products are registered in the US?

559 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental delivery system", from 20 companies. The largest labeler is Ls Enterprises, Inc. with 51% of records.

Which FDA product codes apply?

EIA (Unit, Operative Dental), ELC (Scaler, Ultrasonic), EBW (Controller, foot, handpiece and cord), EBW (Controller, Foot, Handpiece And Cord)

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?

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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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