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Device Explorer · FDA GUDID · GMDN 35865

Polysulfide dental impression material

An elastomeric, polysulfide-based material capable of reacting to form a rubber-like substance used to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a

US‑registered devices65in commercial distribution
Companies2labelers on GUDID
Single‑use78%of device records
Sterile0%labelled sterile
Prescription20%Rx‑only share
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Share of device records

Pearson Dental Supplies, Inc.5382%
Kerr Corporation1218%

Top labelers

CompanyDevicesShare
Pearson Dental Supplies, Inc.5382%
Kerr Corporation1218%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PermlasticVivid Supreme Bite ClearVvid Supreme Bite BlueVivid Elegance Dynamic Putty FSVivid Elegance Putty Hand Mix FSVivid Elegance Putty Hand Mix RSVivid Flavor Match Putty Fast Set BerryVivid Flavor Match Putty Fast Set MintVivid Flavor Match Berry Fast Set MonoVivid Flavor Match Berry Regular Set MonoVivid Flavor Match Berry Fast Set HeavyVivid Flavor Match Berry Regular Set HeavyVivid Flavor Match Berry Fast Set MediumVivid Flavor Match Berry Regular Set MediumVivid Flavor Match Berry Fast Set LightVivid Flavor Match Berry Regular Set Light

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

FDA product codes

CodeNameDevices
ELWMaterial, Impression62

GMDN & GCC registration

  • GMDN code 35865 · non‑implantable
  • Single‑use 78% · sterile 0% · Rx‑only 20% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Gram) · 12

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

How many polysulfide dental impression material products are registered in the US?

65 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polysulfide dental impression material", from 2 companies. The largest labeler is Pearson Dental Supplies, Inc. with 82% of records.

Which FDA product codes apply?

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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