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Device Explorer · FDA GUDID · GMDN 56320

LED dental light, line-powered

A mains electricity (AC-powered) device designed for use in dentistry to project an intense focused beam of light directly into or around the oral cavity of a patient via a light-emitting diode (LED) situated as the light head at the distal end of the device's

US‑registered devices401in commercial distribution
Companies15labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription30%Rx‑only share
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Share of device records

Dentis Co. ,Ltd11930%
Midmark Corporation8621%
Ls Enterprises, Inc.6015%
Dci International, Llc5714%
Dentalez Alabama, Inc.256%
A-Dec, Inc.225%
Medfruition Electronics Technology Co., Ltd102%
Jmu Dental, Inc92%

Top labelers

CompanyDevicesShare
Dentis Co. ,Ltd11930%
Midmark Corporation8621%
Ls Enterprises, Inc.6015%
Dci International, Llc5714%
Dentalez Alabama, Inc.256%
A-Dec, Inc.225%
Medfruition Electronics Technology Co., Ltd102%
Jmu Dental, Inc92%
Foshan Coxo Medical Instrument Co.,Ltd.41%
Sirona Dental Systems Gmbh31%
Planmeca Oy20%
Chuan Fu Medical Instrument Co., Ltd.10%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

COXODental Operating LightPlanmeca SolannaPlanmeca SingLEDLED Operating LightCeiling ModellLEDview plusMidmarkJMUDCI EdgeForestDentalezSmartLite® Pro LED Modular Curing LightA-decDental LightLUVIS-C500 Series

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

FDA product codes

CodeNameDevices
EAZLight, Operating, Dental321
EAZLIGHT, OPERATING, DENTAL95
EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION1
FTDLamp, Surgical1

GMDN & GCC registration

  • GMDN code 56320 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 30% · 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 led dental light, line-powered products are registered in the US?

401 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "LED dental light, line-powered", from 15 companies. The largest labeler is Dentis Co. ,Ltd with 30% of records.

Which FDA product codes apply?

EAZ (Light, Operating, Dental), EAZ (LIGHT, OPERATING, DENTAL), EBZ (ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION), FTD (Lamp, Surgical)

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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