Consulting Wallah › Device Explorer › Dental › Dental wedge, single-use
Device Explorer · FDA GUDID · GMDN 45007

Dental wedge, single-use

A small, dental device intended to be introduced between two adjacent teeth for slight separation during a dental procedure. It is typically used during the placement of a filling material, or to stabilize and support other devices (e.g., a matrix band and/or

US‑registered devices422in commercial distribution
Companies29labelers on GUDID
Single‑use98%of device records
Sterile0%labelled sterile
Prescription51%Rx‑only share
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Share of device records

Garrison Dental Solutions, L.L.C.8320%
Bioclear Matrix Systems7117%
Polydentia Sa5714%
Directa Ab358%
Keystone Industries205%
Maxill, Inc.154%
Jmu Dental, Inc133%
Dentsply International Inc.133%

Top labelers

CompanyDevicesShare
Garrison Dental Solutions, L.L.C.8320%
Bioclear Matrix Systems7117%
Polydentia Sa5714%
Directa Ab358%
Keystone Industries205%
Maxill, Inc.154%
Jmu Dental, Inc133%
Dentsply International Inc.133%
Clinician'S Choice Dental Products, Inc.123%
Premier Dental Products Company123%
Den-Mat Holdings, Llc113%
Ultradent Products, Inc.92%

Company = labeler of record on GUDID. 29 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Contoured Wood Wedges AssortedContoured Wood Wedges 17mm White RefillContoured Wood Wedges 15mm Yellow RefillContoured Wood Wedges 13mm Green RefillContoured Wood Wedges 12mm Blue RefillContoured Wood Wedges 11mm Pink RefillEna Matrix3wedgemyWedgethe wedgetransparent wedgeswood wedgesMacro-WedgesHemo-wedgeOrange wood wedgesorange wood wedges

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

FDA product codes

CodeNameDevices
EJBHandle, Instrument, Dental153
DZNInstruments, Dental Hand113
DZNINSTRUMENTS, DENTAL HAND76
JEPRetainer, Matrix58
EIYInstrument, Filling, Plastic, Dental11
ECIBand, Elastic, Orthodontic7

GMDN & GCC registration

  • GMDN code 45007 · non‑implantable
  • Single‑use 98% · sterile 0% · Rx‑only 51% · 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

Length (Millimeter) · 27Width (Millimeter) · 16

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

How many dental wedge, single-use products are registered in the US?

422 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental wedge, single-use", from 29 companies. The largest labeler is Garrison Dental Solutions, L.L.C. with 20% of records.

Which FDA product codes apply?

EJB (Handle, Instrument, Dental), DZN (Instruments, Dental Hand), DZN (INSTRUMENTS, DENTAL HAND), JEP (Retainer, Matrix)

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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