Consulting Wallah › Device Explorer › Dental › Dental material cartridge-plunging applicator, two
Device Explorer · FDA GUDID · GMDN 60885

Dental material cartridge-plunging applicator, two-component, manual

A hand-held manual device intended to dispense a two-component dental material (e.g., impression material) [not included] from a cartridge directly into the mouth or into another device (e.g., impression tray). It is typically a pistol-like device with a cartr

US‑registered devices120in commercial distribution
Companies29labelers on GUDID
Single‑use12%of device records
Sterile0%labelled sterile
Prescription75%Rx‑only share
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Share of device records

3M Deutschland Gmbh3227%
Peter Brasseler Holdings, Llc1613%
Kerr Corporation87%
3M Company43%
Safco Dental Supply Co.43%
3D Dental Designs And Development, Llc43%
Parkell, Inc.43%
Gc America Inc.43%

Top labelers

CompanyDevicesShare
3M Deutschland Gmbh3227%
Peter Brasseler Holdings, Llc1613%
Kerr Corporation87%
3M Company43%
Safco Dental Supply Co.43%
3D Dental Designs And Development, Llc43%
Parkell, Inc.43%
Gc America Inc.43%
Top Quality Manufacturing, Inc.43%
Clinician'S Choice Dental Products, Inc.32%
Dmg Chemisch-Pharmazeutische Fabrik Gmbh32%
Darby Dental Supply, Llc32%

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

Brand names on the register (sample)

Mini 1:1 Dispensing GunTemptation Now / Inspire Dispensing GunDual Port Impression GunTOKUYAMA DISPENSER II3M™ Garant™3M™ Maxicap™3M™ Aplicap™Automix-Dispenser Type 50 1:1Automix-Dispenser Type 50 10:1Automix-Dispenser Type 25 1:13M™3M™ ESPE™ Impregum™3M™ Protemp™Ketac™ Cem Aplicap™Imprint™ 4 BiteRelyX™ Unicem Maxicap™

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 MATERIAL53
DZNINSTRUMENTS, DENTAL HAND23
EIDSyringe, Restorative And Impression Material11
ELWMATERIAL, IMPRESSION8
EMACEMENT, DENTAL8
DZNInstruments, Dental Hand5

GMDN & GCC registration

  • GMDN code 60885 · non‑implantable
  • Single‑use 12% · sterile 0% · Rx‑only 75% · 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

Total Volume (Milliliter) · 2

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

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

120 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, two-component, manual", from 29 companies. The largest labeler is 3M Deutschland Gmbh with 27% of records.

Which FDA product codes apply?

EID (SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL), DZN (INSTRUMENTS, DENTAL HAND), EID (Syringe, Restorative And Impression Material), ELW (MATERIAL, IMPRESSION)

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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