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Device Explorer · FDA GUDID · GMDN 38786

Dental matrix band, single-use

A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a si

US‑registered devices1,128in commercial distribution
Companies41labelers on GUDID
Single‑use95%of device records
Sterile1%labelled sterile
Prescription43%Rx‑only share
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Share of device records

Bioclear Matrix Systems26323%
Garrison Dental Solutions, L.L.C.22120%
Polydentia Sa11911%
Henry Schein, Inc.525%
Ultradent Products, Inc.484%
Dentsply International Inc.484%
Iveneer Ltd424%
Tdv Dental Ltda343%

Top labelers

CompanyDevicesShare
Bioclear Matrix Systems26323%
Garrison Dental Solutions, L.L.C.22120%
Polydentia Sa11911%
Henry Schein, Inc.525%
Ultradent Products, Inc.484%
Dentsply International Inc.484%
Iveneer Ltd424%
Tdv Dental Ltda343%
Plasdent Corporation282%
3M Company262%
3D Dental Designs And Development, Llc222%
Clinician'S Choice Dental Products, Inc.182%

Company = labeler of record on GUDID. 41 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Dual-Force™ Sectional Matrix System Ultra-Wrap TDual-Force™ Sectional Matrix System Ultra-Wrap MDual-Force™ Sectional Matrix System Ultra-Wrap MDual-Force™ Sectional Matrix System Ultra-Wrap MDual-Force™ Sectional Matrix System Wedge KitDual-Force™ Sectional Matrix System Matrix Band Dual-Force™ Sectional Matrix System Matrix Band Dual-Force™ Sectional Matrix System Matrix Band Dual-Force™ Sectional Matrix System Active-WedgeDual-Force™ Sectional Matrix System Active-WedgeDual-Force™ Sectional Matrix System Active-WedgeDual-Force™ Sectional Matrix System Active-WedgeDual-Force™ Sectional Matrix System Active-WedgeConvexi-T™ S2 Stainless Steel Convex Tofflemire™Convexi-T™ S2 Stainless Steel Convex Tofflemire™Convexi-T™ Convex Toflemire™ Matrix Bands 5.5mm

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

FDA product codes

CodeNameDevices
JEPRetainer, Matrix580
DZNInstruments, Dental Hand191
DZNINSTRUMENTS, DENTAL HAND125
JEPRETAINER, MATRIX86
EKFInstrument, Contouring, Matrix, Operative71
KCQTube Impression And Matrix40

GMDN & GCC registration

  • GMDN code 38786 · non‑implantable
  • Single‑use 95% · sterile 1% · Rx‑only 43% · 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

Height (Millimeter) · 87Lumen/Inner Diameter (Millimeter) · 20Depth (Inch) · 16

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

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

1,128 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental matrix band, single-use", from 41 companies. The largest labeler is Bioclear Matrix Systems with 23% of records.

Which FDA product codes apply?

JEP (Retainer, Matrix), 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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