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Device Explorer · FDA GUDID · GMDN 34811

Polymer-based dental model material

A variety of dental materials dedicated for modelling and for use during production of dental restorations. It is based on various kinds of polymers. After application, this device cannot be reused.

US‑registered devices233in commercial distribution
Companies3labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription1%Rx‑only share
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Share of device records

Talladium, Inc.23199%
Voco Gmbh10%
Vita - Zahnfabrik H. Rauter Gesellschaft Mit Beschränkter Haftung & Co Kommanditgesellschaft10%

Top labelers

CompanyDevicesShare
Talladium, Inc.23199%
Voco Gmbh10%
Vita - Zahnfabrik H. Rauter Gesellschaft Mit Beschränkter Haftung & Co Kommanditgesellschaft10%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

die siliconeLuminesse Clear PMMA DiscsLuminesse Multi-Layer PMMA DiscsLuminesse Super Clear PMMA DiscsLuminesse Shaded PMMA DiscsLuminesse Shaded PMMA DiscsqVITAVM LC

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

FDA product codes

CodeNameDevices
EBGCrown And Bridge, Temporary, Resin229
EBFMATERIAL, TOOTH SHADE, RESIN4
ELWMATERIAL, IMPRESSION2
EBHMaterial, Impression Tray, Resin1
EBECoating, Denture Hydrophilic, Resin1
EBFMaterial, Tooth Shade, Resin1

GMDN & GCC registration

  • GMDN code 34811 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 1% · 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

No structured size data on the register.

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

How many polymer-based dental model material products are registered in the US?

233 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polymer-based dental model material", from 3 companies. The largest labeler is Talladium, Inc. with 99% of records.

Which FDA product codes apply?

EBG (Crown And Bridge, Temporary, Resin), EBF (MATERIAL, TOOTH SHADE, RESIN), ELW (MATERIAL, IMPRESSION), EBH (Material, Impression Tray, Resin)

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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