Device Explorer · FDA GUDID · GMDN 35701

Fluoride gel tray

A device typically made of styrofoam that is used to apply fluoride topically to the teeth. The device is designed to conform to the human mouth; a patient bites down on the device after it has been filled with a fluoride gel or solution for application.

US‑registered devices94in commercial distribution
Companies17labelers on GUDID
Single‑use99%of device records
Sterile0%labelled sterile
Prescription41%Rx‑only share
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Share of device records

Plasdent Corporation1213%
Darby Dental Supply, Llc1112%
Scott'S Dental Supply L.L.C.77%
Dental Health Products Inc77%
Sultan Healthcare Inc77%
Vista Dental77%
The Atlanta Dental Supply Company77%
Premium Plus (Dongguan) Limited66%

Top labelers

CompanyDevicesShare
Plasdent Corporation1213%
Darby Dental Supply, Llc1112%
Scott'S Dental Supply L.L.C.77%
Dental Health Products Inc77%
Sultan Healthcare Inc77%
Vista Dental77%
The Atlanta Dental Supply Company77%
Premium Plus (Dongguan) Limited66%
Young Dental Manufacturing I, Llc66%
Amd Medicom Inc66%
Kerr Corporation44%
Young Innovations, Inc.33%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Darby Dental Supply, LLCFluoride Gel Tray 25-pkPlasdentThe Orthodontic StoreSCOTT'S DUAL ARCH TRAYS 100/bag LARGE (BLUE)SCOTT'S DUAL ARCH TRAYS 100/bag MEDIUM (WHITE)SCOTT'S DUAL ARCH TRAYS 100/bag SMALL (YELLOW)SCOTT'S DUAL ARCH TRAYS 100/bag PEDO (GREEN)SCOTT'S SINGLE FLUORIDE TRAYS 100/bag (LARGE)SCOTT'S SINGLE FLUORIDE TRAYS 100/bag (MEDIUM)SCOTT'S SINGLE FLUORIDE TRAYS 100/bag (SMALL)Health-Tec/DHP Fluoride TraysTopex®Turbo-CRPremium PlusNUPRO®

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

FDA product codes

CodeNameDevices
KMTTRAY, FLUORIDE, DISPOSABLE55
KMTTray, Fluoride, Disposable24
EBHMaterial, Impression Tray, Resin12
EHYTRAY, IMPRESSION, PREFORMED3

GMDN & GCC registration

  • GMDN code 35701 · non‑implantable
  • Single‑use 99% · sterile 0% · Rx‑only 41% · OTC 6%
  • 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.

No closely related category with 50+ devices.

How many fluoride gel tray products are registered in the US?

94 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Fluoride gel tray", from 17 companies. The largest labeler is Plasdent Corporation with 13% of records.

Which FDA product codes apply?

KMT (TRAY, FLUORIDE, DISPOSABLE), KMT (Tray, Fluoride, Disposable), EBH (Material, Impression Tray, Resin), EHY (TRAY, IMPRESSION, PREFORMED)

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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