Consulting Wallah › Device Explorer › Dental › Dental impression tray, single-use
Device Explorer · FDA GUDID · GMDN 16350

Dental impression tray, single-use

A horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets

US‑registered devices1,607in commercial distribution
Companies76labelers on GUDID
Single‑use97%of device records
Sterile1%labelled sterile
Prescription52%Rx‑only share
ShareLinkedIn

Share of device records

Smart Denture Conversions, Llc23415%
Plasdent Corporation1228%
Young Innovations, Inc.1147%
Clinician'S Choice Dental Products, Inc.795%
Den-Mat Holdings, Llc735%
Cowellmedi Co.,Ltd584%
Good Fit Technologies, Llc533%
Darby Dental Supply, Llc453%

Top labelers

CompanyDevicesShare
Smart Denture Conversions, Llc23415%
Plasdent Corporation1228%
Young Innovations, Inc.1147%
Clinician'S Choice Dental Products, Inc.795%
Den-Mat Holdings, Llc735%
Cowellmedi Co.,Ltd584%
Good Fit Technologies, Llc533%
Darby Dental Supply, Llc453%
Gc America Inc.443%
Premium Plus (Dongguan) Limited433%
Benco Dental Supply Co.433%
Premier Dental Products Company332%

Company = labeler of record on GUDID. 76 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Quad-Tray® Ultimate™ Posterior SampleQuad-Tray® Ultimate™ Posterior 250PKQuad-Tray® Ultimate™ Posterior 50PKQuad-Tray® Ultimate™ Posterior BULKBorder-Lock® Green Mouldable Upper Dentulous TraBorder-Lock® Green Mouldable Upper Dentulous TraBorder-Lock® Green Mouldable Lower Dentulous TraBorder-Lock® Green Mouldable Lower Dentulous TraBorder-Lock® Green Mouldable Lower Dentulous TraBorder-Lock® Green Mouldable Lower Dentulous TraBorder-Lock® Green Mouldable Lower Dentulous TraBorder-Lock® Green Mouldable Lower Dentulous TraBorder-Lock® Green Mouldable Lower Dentulous TraBorder-Lock® Green Mouldable Lower Dentulous TraBorder-Lock® Green Mouldable Upper Dentulous TraBorder-Lock® Green Mouldable Upper Dentulous Tra

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

FDA product codes

CodeNameDevices
EHYTray, Impression, Preformed761
EHYTRAY, IMPRESSION, PREFORMED554
EBHMaterial, Impression Tray, Resin241
EBHMATERIAL, IMPRESSION TRAY, RESIN79
NDPAccessories, Implant, Dental, Endosseous65
NRDUnit, Operative Dental, Accessories9

GMDN & GCC registration

  • GMDN code 16350 · non‑implantable
  • Single‑use 97% · sterile 1% · Rx‑only 52% · OTC 1%
  • 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 impression tray, single-use products are registered in the US?

1,607 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental impression tray, single-use", from 76 companies. The largest labeler is Smart Denture Conversions, Llc with 15% of records.

Which FDA product codes apply?

EHY (Tray, Impression, Preformed), EHY (TRAY, IMPRESSION, PREFORMED), EBH (Material, Impression Tray, Resin), 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?

Add dental impression tray, single-use to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Dental impression tray, single-use

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying dental impression tray, single-use for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →