Device Explorer · FDA GUDID · GMDN 34808

Dental base plate

A foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). This is a single-use device.

US‑registered devices126in commercial distribution
Companies15labelers on GUDID
Single‑use80%of device records
Sterile0%labelled sterile
Prescription79%Rx‑only share
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Share of device records

Yamahachi Dental Mfg.,Co.5443%
Coltene/Whaledent Inc1915%
Wright Health Group Limited108%
Voco Gmbh97%
Cavex Holland B.V.65%
Shandong Huge Dental Material Corporation54%
Pro3Dure Medical Gmbh54%
Denplus Inc43%

Top labelers

CompanyDevicesShare
Yamahachi Dental Mfg.,Co.5443%
Coltene/Whaledent Inc1915%
Wright Health Group Limited108%
Voco Gmbh97%
Cavex Holland B.V.65%
Shandong Huge Dental Material Corporation54%
Pro3Dure Medical Gmbh54%
Denplus Inc43%
Changshu Shangchi Dental Materials Co., Ltd.32%
Deltamed Gmbh32%
Benco Dental Supply Co.32%
Cmp Industries Llc22%

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

Brand names on the register (sample)

DENTAL WAXTry-inDentoriumWrightsLight Resin PlateRS VIVO Try-InP pro Try-In3Delta Try-In XTCavex Baseplate mica-free lowersCavex Baseplate lowersCavex Baseplate uppers Double ThicknessCavex Baseplate mica-free uppersCavex Baseplate uppersCavex Individual Trays uppers plainIndivido LuxProfibase

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

FDA product codes

CodeNameDevices
EGDWax, Dental, Intraoral72
EBHMaterial, Impression Tray, Resin32
EEAPlate, Base, Shellac27
EBHMATERIAL, IMPRESSION TRAY, RESIN1

GMDN & GCC registration

  • GMDN code 34808 · non‑implantable
  • Single‑use 80% · sterile 0% · Rx‑only 79% · OTC 5%
  • 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 base plate products are registered in the US?

126 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental base plate", from 15 companies. The largest labeler is Yamahachi Dental Mfg.,Co. with 43% of records.

Which FDA product codes apply?

EGD (Wax, Dental, Intraoral), EBH (Material, Impression Tray, Resin), EEA (Plate, Base, Shellac), EBH (MATERIAL, IMPRESSION TRAY, RESIN)

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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