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Device Explorer · FDA GUDID · GMDN 35870

Dental composite resin

A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or d

US‑registered devices9,253in commercial distribution
Companies118labelers on GUDID
Single‑use38%of device records
Sterile1%labelled sterile
Prescription87%Rx‑only share
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Share of device records

Ivoclar Vivadent Aktiengesellschaft7078%
Gc America Inc.5706%
Shofu Dental Corporation4195%
Voco Gmbh4044%
Cosmedent, Inc.3924%
Micerium Spa3053%
3M Company3053%
Ultradent Products, Inc.2973%

Top labelers

CompanyDevicesShare
Ivoclar Vivadent Aktiengesellschaft7078%
Gc America Inc.5706%
Shofu Dental Corporation4195%
Voco Gmbh4044%
Cosmedent, Inc.3924%
Micerium Spa3053%
3M Company3053%
Ultradent Products, Inc.2973%
Scientific Pharmaceuticals, Inc.2923%
Kulzer Gmbh2823%
Kerr Corporation2693%
Deltamed Gmbh2543%

Company = labeler of record on GUDID. 118 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HeliomolarHeliomolar FlowHelioseal/Clear/F/F PlusHeliomolar HBTetric EvoCeramTetric EvoFlowMultilink Automix / Primer A+BIPS Empress DirectMultilink Hybrid AbutmentVariolink EstheticTetric PowerFillSpeedCEM / SpeedCEM PlusTetric PowerFlowTetric 100 Bulk FillTetric 100 Bulk FlowTetric 100 Universal

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, Resin5,136
EBFMATERIAL, TOOTH SHADE, RESIN2,586
EBFMaterial, tooth shade, resin1,361
EMACement, Dental700
EMACEMENT, DENTAL480
EBCSealant, Pit And Fissure, And Conditioner176

GMDN & GCC registration

  • GMDN code 35870 · non‑implantable
  • Single‑use 38% · sterile 1% · Rx‑only 87% · OTC 1%
  • 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) · 1,413Total Volume (Milliliter) · 408Needle Gauge (Gauge) · 19Total Volume (Fluid Ounce) · 3

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

How many dental composite resin products are registered in the US?

9,253 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental composite resin", from 118 companies. The largest labeler is Ivoclar Vivadent Aktiengesellschaft with 8% of records.

Which FDA product codes apply?

EBF (Material, Tooth Shade, Resin), EBF (MATERIAL, TOOTH SHADE, RESIN), EBF (Material, tooth shade, resin), EMA (Cement, Dental)

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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