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Device Explorer · FDA GUDID · GMDN 58106

Dental impression tray material

A material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a prelimi

US‑registered devices164in commercial distribution
Companies24labelers on GUDID
Single‑use71%of device records
Sterile0%labelled sterile
Prescription52%Rx‑only share
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Share of device records

Lang Dental Manufacturing Co., Inc.3119%
Vertex-Dental B.V.2716%
Reliance Dental Manufacturing Co Inc2314%
Denplus Inc1610%
Fricke International, Inc.117%
Garreco, Llc95%
Ivoclar Vivadent Aktiengesellschaft85%
Deltamed Gmbh53%

Top labelers

CompanyDevicesShare
Lang Dental Manufacturing Co., Inc.3119%
Vertex-Dental B.V.2716%
Reliance Dental Manufacturing Co Inc2314%
Denplus Inc1610%
Fricke International, Inc.117%
Garreco, Llc95%
Ivoclar Vivadent Aktiengesellschaft85%
Deltamed Gmbh53%
Dmg Digital Enterprises Se42%
Yamahachi Dental Mfg.,Co.42%
Dreve Dentamid Gmbh32%
D.S.I Dental Solutions Ltd32%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SR IvolenPionextMegatrayE-TrayRS VIVO TrayP pro Impression Tray Green3Delta Tray Rose3Delta TrayBisi-TrayFotoDent® tray2C-PLASTProArt CAD Try inLuxaPrint TrayUniLite Blockout Material 5 syringesDSI Implant Jig Paste Light-Curing Resin for PatJig Sculpting Paste Light-Curing for Pattern Mod

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

FDA product codes

CodeNameDevices
EBHMaterial, Impression Tray, Resin123
EBHMATERIAL, IMPRESSION TRAY, RESIN49
ELWMATERIAL, IMPRESSION4
EHYTray, Impression, Preformed2
ELMDenture, plastic, teeth2
EEAPlate, Base, Shellac1

GMDN & GCC registration

  • GMDN code 58106 · non‑implantable
  • Single‑use 71% · sterile 0% · Rx‑only 52% · 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

Weight (Pound) · 9Weight (Gram) · 2Total Volume (Quart) · 1Total Volume (Fluid Ounce) · 1

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

How many dental impression tray material products are registered in the US?

164 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental impression tray material", from 24 companies. The largest labeler is Lang Dental Manufacturing Co., Inc. with 19% of records.

Which FDA product codes apply?

EBH (Material, Impression Tray, Resin), EBH (MATERIAL, IMPRESSION TRAY, RESIN), ELW (MATERIAL, IMPRESSION), 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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