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Device Explorer · FDA GUDID · GMDN 34771

Dental unfilled resin sealant/coating

A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the settin

US‑registered devices320in commercial distribution
Companies35labelers on GUDID
Single‑use36%of device records
Sterile0%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Id Korea Co., Ltd.6320%
Pac-Dent, Inc.3912%
Gc America Inc.3812%
Ultradent Products, Inc.3210%
Vita - Zahnfabrik H. Rauter Gesellschaft Mit Beschränkter Haftung & Co Kommanditgesellschaft278%
Shofu Dental Corporation217%
Voco Gmbh165%
3M Company124%

Top labelers

CompanyDevicesShare
Id Korea Co., Ltd.6320%
Pac-Dent, Inc.3912%
Gc America Inc.3812%
Ultradent Products, Inc.3210%
Vita - Zahnfabrik H. Rauter Gesellschaft Mit Beschränkter Haftung & Co Kommanditgesellschaft278%
Shofu Dental Corporation217%
Voco Gmbh165%
3M Company124%
Tulsa Dental Products Llc72%
Rizhao Huge Biomaterials Company, Ltd.62%
Dmg Chemisch-Pharmazeutische Fabrik Gmbh52%
Pulpdent Corporation52%

Company = labeler of record on GUDID. 35 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ResinBlend LV Composite Blending Resin Unit DoseResinBlend LV Composite Blending ResinGlisten™ Provisional Resin GlazeQuick SealEnamel Coating ResinEna Seal ®SURFACE COAT™Icon®Icon-Etch RefillKetac™ GlazeSHOFU RESIN GLAZELITE ARTBeautiSealantVOCO Profluorid VarnishAdmira ProtectProfluorid L

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

FDA product codes

CodeNameDevices
EBDCoating, Filling Material, Resin113
EBFMATERIAL, TOOTH SHADE, RESIN78
EBCSEALANT, PIT AND FISSURE, AND CONDITIONER58
EBDCoating, filling material, resin53
EBCSealant, Pit And Fissure, And Conditioner32
EBFMaterial, Tooth Shade, Resin25

GMDN & GCC registration

  • GMDN code 34771 · non‑implantable
  • Single‑use 36% · sterile 0% · Rx‑only 97% · 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

Total Volume (Milliliter) · 77Weight (Gram) · 54

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

How many dental unfilled resin sealant/coating products are registered in the US?

320 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental unfilled resin sealant/coating", from 35 companies. The largest labeler is Id Korea Co., Ltd. with 20% of records.

Which FDA product codes apply?

EBD (Coating, Filling Material, Resin), EBF (MATERIAL, TOOTH SHADE, RESIN), EBC (SEALANT, PIT AND FISSURE, AND CONDITIONER), EBD (Coating, filling material, 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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