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Device Explorer · FDA GUDID · GMDN 16196

Dental material cartridge-plunging applicator, single-component

A hand-held manual device intended to dispense a single-component dental material (not included) from a cartridge directly into the mouth; it is not intended to dispense more than one component simultaneously. It is typically a pistol-like device with a cartri

US‑registered devices61in commercial distribution
Companies25labelers on GUDID
Single‑use5%of device records
Sterile0%labelled sterile
Prescription61%Rx‑only share
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Share of device records

Centrix, Inc.1423%
Plasdent Corporation1016%
Jmu Dental, Inc47%
Young Innovations, Inc.35%
Novabone Products, Llc35%
American Medicals35%
Angelus Industria De Produtos Odontologicos S A35%
Septodont Sas Specialites Septodont23%

Top labelers

CompanyDevicesShare
Centrix, Inc.1423%
Plasdent Corporation1016%
Jmu Dental, Inc47%
Young Innovations, Inc.35%
Novabone Products, Llc35%
American Medicals35%
Angelus Industria De Produtos Odontologicos S A35%
Septodont Sas Specialites Septodont23%
Dentsply De Trey Gmbh23%
Den-Mat Holdings, Llc23%
Clinician'S Choice Dental Products, Inc.12%
Dmg Chemisch-Pharmazeutische Fabrik Gmbh12%

Company = labeler of record on GUDID. 25 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Compo-Ject™Safetip Dispenser ProBiodentine Applicator (Gun)OrmcoAdDentPlasdentJMUAstekCompule GunUnit Dose Dispensing SyringeEZMultiMatchSnap FitMark IIMark IIIMark I

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

FDA product codes

CodeNameDevices
EIDSyringe, Restorative And Impression Material27
NRDUnit, Operative Dental, Accessories10
DZNINSTRUMENTS, DENTAL HAND7
MDMInstrument, Manual, Surgical, General Use3
EKICarrier, Amalgam, Operative3
EJBHandle, Instrument, Dental2

GMDN & GCC registration

  • GMDN code 16196 · non‑implantable
  • Single‑use 5% · sterile 0% · Rx‑only 61% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Centimeter) · 1

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

How many dental material cartridge-plunging applicator, single-component products are registered in the US?

61 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental material cartridge-plunging applicator, single-component", from 25 companies. The largest labeler is Centrix, Inc. with 23% of records.

Which FDA product codes apply?

EID (Syringe, Restorative And Impression Material), NRD (Unit, Operative Dental, Accessories), DZN (INSTRUMENTS, DENTAL HAND), MDM (Instrument, Manual, Surgical, General Use)

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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