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Device Explorer · FDA GUDID · GMDN 12351

Reflective dental room light

A mains electricity (AC-powered) device designed for use in dentistry to project an intense and focused beam of light typically into or around the oral cavity of a patient to illuminate the site of a dental examination or procedure. It is constructed as a curv

US‑registered devices134in commercial distribution
Companies8labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription40%Rx‑only share
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Share of device records

Midmark Corporation4836%
Takara Belmont Corp.4030%
F.A.R.O. Fabbrica Apparecchiature Razionali Odontoiatriche Spa2116%
Cefla Societa' Cooperativa1410%
Plasdent Corporation86%
Proma, Inc.11%
A-Dec, Inc.11%
Aiobio Co.,Ltd11%

Top labelers

CompanyDevicesShare
Midmark Corporation4836%
Takara Belmont Corp.4030%
F.A.R.O. Fabbrica Apparecchiature Razionali Odontoiatriche Spa2116%
Cefla Societa' Cooperativa1410%
Plasdent Corporation86%
Proma, Inc.11%
A-Dec, Inc.11%
Aiobio Co.,Ltd11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Bel-Halo Dental LightCLESTA LED DENTAL LIGHTBel-Nova LEDBel-Halo LEDPlasdentMidmarkPromaA-decAIOBIOFAROCEFLA

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, Dental77
EAZLIGHT, OPERATING, DENTAL57
NRDUnit, Operative Dental, Accessories8
KYTLight, Examination, Medical, Battery Powered1

GMDN & GCC registration

  • GMDN code 12351 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 40% · 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 reflective dental room light products are registered in the US?

134 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Reflective dental room light", from 8 companies. The largest labeler is Midmark Corporation with 36% of records.

Which FDA product codes apply?

EAZ (Light, Operating, Dental), EAZ (LIGHT, OPERATING, DENTAL), NRD (Unit, Operative Dental, Accessories), KYT (Light, Examination, Medical, Battery 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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