Consulting Wallah › Device Explorer › Syringes, needles & infusion › Dental impression material syringe, single-use
Device Explorer · FDA GUDID · GMDN 58894

Dental impression material syringe, single-use

A non-sterile, hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient?s mouth. This is a single-use device.

US‑registered devices60in commercial distribution
Companies17labelers on GUDID
Single‑use100%of device records
Sterile2%labelled sterile
Prescription55%Rx‑only share
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Share of device records

Vista Dental1525%
Kettenbach Gmbh & Co. Kg1017%
Zogear Medical Co., Ltd.813%
Osstem Implant Co.,Ltd.58%
Plasdent Corporation47%
Premium Plus (Dongguan) Limited47%
Unipack Medical Corporation23%
Bgss Company Inc.23%

Top labelers

CompanyDevicesShare
Vista Dental1525%
Kettenbach Gmbh & Co. Kg1017%
Zogear Medical Co., Ltd.813%
Osstem Implant Co.,Ltd.58%
Plasdent Corporation47%
Premium Plus (Dongguan) Limited47%
Unipack Medical Corporation23%
Bgss Company Inc.23%
Henry Schein, Inc.23%
Darby Dental Supply, Llc12%
Bright Supply, Inc.12%
Ultradent Products, Inc.12%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Dynamic MixersMixing TipsDarby Dental Supply, LLCBritedentThermo ClonePlastcarePlasdentUnipackSafco Multipurpose Curved Utility SyringesSAFE DENTPremium PlusTop Quality ManufacturingCanalPro Color Syringes6cc Dripless SyringeVista White Color-Coded 3cc syringeVista Yellow Color-Coded 3cc syringe

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 Material22
EICSyringe, Periodontic, Endodontic, Irrigating22
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL10
NRDUnit, Operative Dental, Accessories4
EIBSyringe, Irrigating (Dental)2
ELWMATERIAL, IMPRESSION1

GMDN & GCC registration

  • GMDN code 58894 · non‑implantable
  • Single‑use 100% · sterile 2% · Rx‑only 55% · OTC 5%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

How many dental impression material syringe, single-use products are registered in the US?

60 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental impression material syringe, single-use", from 17 companies. The largest labeler is Vista Dental with 25% of records.

Which FDA product codes apply?

EID (Syringe, Restorative And Impression Material), EIC (Syringe, Periodontic, Endodontic, Irrigating), EID (SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL), NRD (Unit, Operative Dental, Accessories)

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.

How do I get quotes?

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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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