Consulting Wallah › Device Explorer › Dental › Dental appliance fabrication material, resin
Device Explorer · FDA GUDID · GMDN 16730

Dental appliance fabrication material, resin

A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period

US‑registered devices4,378in commercial distribution
Companies75labelers on GUDID
Single‑use48%of device records
Sterile0%labelled sterile
Prescription62%Rx‑only share
ShareLinkedIn

Share of device records

Fricke International, Inc.79818%
Vertex-Dental B.V.3829%
Keystone Industries2646%
Pac-Dent, Inc.2375%
Yamahachi Dental Mfg.,Co.2345%
Sprintray, Inc.1995%
Jbc And Company1684%
Lang Dental Manufacturing Co., Inc.1674%

Top labelers

CompanyDevicesShare
Fricke International, Inc.79818%
Vertex-Dental B.V.3829%
Keystone Industries2646%
Pac-Dent, Inc.2375%
Yamahachi Dental Mfg.,Co.2345%
Sprintray, Inc.1995%
Jbc And Company1684%
Lang Dental Manufacturing Co., Inc.1674%
Denplus Inc1584%
Garreco, Llc1293%
Candulor Ag1183%
Ivoclar Vivadent Aktiengesellschaft1163%

Company = labeler of record on GUDID. 75 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

IvotionIvotion BaseProBase Hot / ProBase ColdMED610-DSGMED610TrueDentIBTTrayDental ModelGingiva MaskSurgical GuidePionextSHINING 3D®UltraPrint Hard Splint UVUltraPrint Surgical Guide UVUltraPrint Flexible Denture UV

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, Rebasing2,498
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING1,570
EBFMaterial, Tooth Shade, Resin445
PZYAdditively Manufactured, Preformed, Resin Denture Tooth201
ELMDenture, Plastic, Teeth134
EBGCrown And Bridge, Temporary, Resin121

GMDN & GCC registration

  • GMDN code 16730 · non‑implantable
  • Single‑use 48% · sterile 0% · Rx‑only 62% · 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 (Pound) · 691Weight (Gram) · 493Total Volume (Milliliter) · 198Weight (Kilogram) · 193Total Volume (Fluid Ounce) · 76Total Volume (Liter) · 64

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

How many dental appliance fabrication material, resin products are registered in the US?

4,378 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental appliance fabrication material, resin", from 75 companies. The largest labeler is Fricke International, Inc. with 18% of records.

Which FDA product codes apply?

EBI (Resin, Denture, Relining, Repairing, Rebasing), EBI (RESIN, DENTURE, RELINING, REPAIRING, REBASING), EBF (Material, Tooth Shade, Resin), PZY (Additively Manufactured, Preformed, Resin Denture Tooth)

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?

Add dental appliance fabrication material, resin to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Dental appliance fabrication material, resin

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying dental appliance fabrication material, resin for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →