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Device Explorer · FDA GUDID · GMDN 38781

Dental prosthesis veneer resin

A dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material ca

US‑registered devices1,151in commercial distribution
Companies13labelers on GUDID
Single‑use16%of device records
Sterile0%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Vita - Zahnfabrik H. Rauter Gesellschaft Mit Beschränkter Haftung & Co Kommanditgesellschaft35130%
Shofu Dental Corporation31627%
Ivoclar Vivadent Aktiengesellschaft27324%
Kulzer Gmbh1049%
Bredent Gmbh & Co. Kg212%
Young Innovations, Inc.212%
Dio Corporation192%
Graphy Inc.182%

Top labelers

CompanyDevicesShare
Vita - Zahnfabrik H. Rauter Gesellschaft Mit Beschränkter Haftung & Co Kommanditgesellschaft35130%
Shofu Dental Corporation31627%
Ivoclar Vivadent Aktiengesellschaft27324%
Kulzer Gmbh1049%
Bredent Gmbh & Co. Kg212%
Young Innovations, Inc.212%
Dio Corporation192%
Graphy Inc.182%
Vertex-Dental B.V.111%
Coltene/Whaledent Inc81%
Darby Dental Supply, Llc50%
Reliance Orthodontic Products Inc30%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SR IvocronSR Nexcovisio.lign shield LVvisio.lign shield HVvisio.lign color Yellowvisio.lign color Whitevisio.lign color Starter Kitvisio.lign color Setvisio.lign color Rosevisio.lign color Orangevisio.lign color Olivevisio.lign color Grey-Bluevisio.lign color Gum Redvisio.lign color Gum Pinkvisio.lign color Gum Lightvisio.lign color Creme

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

FDA product codes

CodeNameDevices
EBFMATERIAL, TOOTH SHADE, RESIN556
EBFMaterial, Tooth Shade, Resin286
EBGCROWN AND BRIDGE, TEMPORARY, RESIN213
EBFMaterial, tooth shade, resin195
EBDCoating, filling material, resin107
NDPAccessories, Implant, Dental, Endosseous19

GMDN & GCC registration

  • GMDN code 38781 · non‑implantable
  • Single‑use 16% · sterile 0% · Rx‑only 96% · 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) · 38Total Volume (Milliliter) · 2Total Volume (Fluid Ounce) · 1

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

How many dental prosthesis veneer resin products are registered in the US?

1,151 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental prosthesis veneer resin", from 13 companies. The largest labeler is Vita - Zahnfabrik H. Rauter Gesellschaft Mit Beschränkter Haftung & Co Kommanditgesellschaft with 30% of records.

Which FDA product codes apply?

EBF (MATERIAL, TOOTH SHADE, RESIN), EBF (Material, Tooth Shade, Resin), EBG (CROWN AND BRIDGE, TEMPORARY, RESIN), EBF (Material, tooth shade, 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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