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Device Explorer · FDA GUDID · GMDN 44786

Dental reinforcing fibre

A device used in general restorative dentistry and orthodontic treatment typically as reinforcement of dental polymer-based materials, used for the construction of dental prostheses, i.e., splints, posts, crowns, and bridges. This device is typically made of p

US‑registered devices106in commercial distribution
Companies14labelers on GUDID
Single‑use64%of device records
Sterile0%labelled sterile
Prescription44%Rx‑only share
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Share of device records

Adm, A.S.2019%
Gc America Inc.1413%
Peter Brasseler Holdings, Llc109%
Synca Marketing Inc109%
Polydentia Sa98%
Ribbond, Inc88%
Angelus Industria De Produtos Odontologicos S A88%
Kerr Corporation77%

Top labelers

CompanyDevicesShare
Adm, A.S.2019%
Gc America Inc.1413%
Peter Brasseler Holdings, Llc109%
Synca Marketing Inc109%
Polydentia Sa98%
Ribbond, Inc88%
Angelus Industria De Produtos Odontologicos S A88%
Kerr Corporation77%
Bioloren Srl77%
Practicon, Inc.55%
Glasspan Inc44%
Preat Corporation22%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

F-Splint-Aid & Slim IntrokitFiber-Splint Ortho evolutionF-Splint-Aid SlimFiber-Splint ML Mini Starter KitFiber-Plast 2x48ml + 12 CannuleFiber-Plast 1x48ml + 12 CannuleF-Splint-AidFiber-Splint ML Multi-LayerFiber-SplintBrasseler USATRAUMA - MISCGlasSpan Dental FibereFiberFiber TechnologyConstructRibbond Bondable Reinfocement Ribbond 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, Rebasing76
EBFMaterial, Tooth Shade, Resin31
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING19
ELSSplint, Endodontic Stabilizing9
EBGCROWN AND BRIDGE, TEMPORARY, RESIN4
EBFMATERIAL, TOOTH SHADE, RESIN3

GMDN & GCC registration

  • GMDN code 44786 · non‑implantable
  • Single‑use 64% · sterile 0% · Rx‑only 44% · 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

Width (Millimeter) · 29Length (Millimeter) · 18Length (Centimeter) · 16Height (Millimeter) · 5Weight (Gram) · 4Circumference (Millimeter) · 1

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

How many dental reinforcing fibre products are registered in the US?

106 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental reinforcing fibre", from 14 companies. The largest labeler is Adm, A.S. with 19% of records.

Which FDA product codes apply?

EBI (Resin, Denture, Relining, Repairing, Rebasing), EBF (Material, Tooth Shade, Resin), EBI (RESIN, DENTURE, RELINING, REPAIRING, REBASING), ELS (Splint, Endodontic Stabilizing)

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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