Consulting Wallah › Device Explorer › Dental › Dental material mixing nozzle
Device Explorer · FDA GUDID · GMDN 58399

Dental material mixing nozzle

A device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozz

US‑registered devices878in commercial distribution
Companies54labelers on GUDID
Single‑use83%of device records
Sterile1%labelled sterile
Prescription76%Rx‑only share
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Share of device records

Dent4You Ag23827%
3M Deutschland Gmbh9811%
Kerr Corporation374%
Henry Schein, Inc.334%
Clinician'S Choice Dental Products, Inc.283%
Bisico Bielefelder Dentalsilicone Gmbh & Co. Kg263%
Den-Mat Holdings, Llc263%
Voco Gmbh212%

Top labelers

CompanyDevicesShare
Dent4You Ag23827%
3M Deutschland Gmbh9811%
Kerr Corporation374%
Henry Schein, Inc.334%
Clinician'S Choice Dental Products, Inc.283%
Bisico Bielefelder Dentalsilicone Gmbh & Co. Kg263%
Den-Mat Holdings, Llc263%
Voco Gmbh212%
Scott'S Dental Supply L.L.C.202%
Kettenbach Gmbh & Co. Kg182%
Dental Health Products Inc182%
Crown Delta Corporation182%

Company = labeler of record on GUDID. 54 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Mixing Tip 4.2T 48pkMixing Tip 5.4T 48pkMixing Tip 6.5T 48pkCling2® 25ml Mixing Tip 96pkCling2® 25ml Mixing Tip 24pk2.5 Mixing Tips with 20ga Integrated Needle (BroPowerMix™ Dynamic Mixing Tips6.5 Dual-Port Mixing Tips (12 pack)5.4 Dual-Port Mixing Tips (12 pack)Cling2®/Temptation® Now 1:1 Mixing TipsInspire™/Temptation® Now 76g Syringe Mixing TipsTemptation® 10L Syringe Mixing TipsMegaMix Mixing Tips"6.5 Mixing Tips ""T-mixer"""7.5 Mixing Tips5.4 Dual-Port Mixing Tips (50-pack)

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 Material441
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL334
ELWMATERIAL, IMPRESSION54
DZNInstruments, Dental Hand24
EBGCROWN AND BRIDGE, TEMPORARY, RESIN21
KXRApplicator, Resin18

GMDN & GCC registration

  • GMDN code 58399 · non‑implantable
  • Single‑use 83% · sterile 1% · Rx‑only 76% · OTC 3%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 26

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

How many dental material mixing nozzle products are registered in the US?

878 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental material mixing nozzle", from 54 companies. The largest labeler is Dent4You Ag with 27% of records.

Which FDA product codes apply?

EID (Syringe, Restorative And Impression Material), EID (SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL), ELW (MATERIAL, IMPRESSION), DZN (Instruments, Dental Hand)

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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