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Device Explorer · FDA GUDID · GMDN 16727

Dental prosthesis restorative material, unfilled resin

A material designed to repair dental prostheses that consists of an unfilled polymeric resin. The material works as a bonding agent to provide a strong and long-lasting attachment to the segments of a broken or cracked prosthesis; it typically consists of a si

US‑registered devices689in commercial distribution
Companies12labelers on GUDID
Single‑use98%of device records
Sterile0%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Lang Dental Manufacturing Co., Inc.39057%
Great Lakes Dental Technologies, Ltd.14221%
Yamahachi Dental Mfg.,Co.13419%
Cargus International, Inc51%
Shofu Dental Corporation41%
Patterson Dental Supply, Inc.41%
Deltamed Gmbh30%
Cosmedent, Inc.20%

Top labelers

CompanyDevicesShare
Lang Dental Manufacturing Co., Inc.39057%
Great Lakes Dental Technologies, Ltd.14221%
Yamahachi Dental Mfg.,Co.13419%
Cargus International, Inc51%
Shofu Dental Corporation41%
Patterson Dental Supply, Inc.41%
Deltamed Gmbh30%
Cosmedent, Inc.20%
Synca Marketing Inc20%
Group Practice Solutions Inc.10%
Young Mydent, Llc10%
Vertex-Dental B.V.10%

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

Brand names on the register (sample)

Re-fine BrightACRIFIXPorelain PrimerAZ PrimerCera Resin BondP&R Repair KitMARK3Complete Primer/Unfilled ResinSilanatorBIOCRYL XR 1# KITBIOCRYL X 1# KITBIOCRYL ICE 1QT MONOMERBIOCRYL ICE 5# POLYMERBIOCRYL ICE 8oz MONOMERBIOCRYL ICE 1# POLYMERBIOCRYL ICE 5# KIT

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

FDA product codes

CodeNameDevices
EBIResin, Denture, Relining, Repairing, Rebasing674
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING7
EBGCrown And Bridge, Temporary, Resin6
KLEAgent, Tooth Bonding, Resin5
EMACement, Dental3
EKODenture Preformed (Partially Prefabricated Denture)2

GMDN & GCC registration

  • GMDN code 16727 · non‑implantable
  • Single‑use 98% · sterile 0% · Rx‑only 98% · 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) · 8Length (Millimeter) · 4Weight (Gram) · 1

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

How many dental prosthesis restorative material, unfilled resin products are registered in the US?

689 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental prosthesis restorative material, unfilled resin", from 12 companies. The largest labeler is Lang Dental Manufacturing Co., Inc. with 57% of records.

Which FDA product codes apply?

EBI (Resin, Denture, Relining, Repairing, Rebasing), EBI (RESIN, DENTURE, RELINING, REPAIRING, REBASING), EBG (Crown And Bridge, Temporary, Resin), KLE (Agent, Tooth Bonding, 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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