Consulting Wallah › Device Explorer › Dental › Denture reliner, hard
Device Explorer · FDA GUDID · GMDN 17609

Denture reliner, hard

A denture relining material intended to be applied by a dentist or dental laboratory technician as a permanent coating or lining on the base or tissue-contact surface of a denture and which sets to a hard state. Denture relining is defined as a process of prov

US‑registered devices234in commercial distribution
Companies12labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

3M Deutschland Gmbh13759%
Harry J Bosworth Company4519%
Gc America Inc.146%
Tokuyama Dental Corporation115%
Voco Gmbh83%
Parkell, Inc.42%
Keystone Industries42%
Darby Dental Supply, Llc31%

Top labelers

CompanyDevicesShare
3M Deutschland Gmbh13759%
Harry J Bosworth Company4519%
Gc America Inc.146%
Tokuyama Dental Corporation115%
Voco Gmbh83%
Parkell, Inc.42%
Keystone Industries42%
Darby Dental Supply, Llc31%
Benco Dental Supply Co.31%
Patterson Dental Supply, Inc.31%
Park Dental Research Corp10%
Henry Schein, Inc.10%

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

Brand names on the register (sample)

TOKUYAMA REBASETOKUYAMA REBASE IIITokuyama Rebase IITOKUSO Resin Hardner IITokuso Resin Hardner IITokuso Rebase MR BondSinfony™CoJet™CediTECUfi Gel hard CQuick UpQuick Up LCDarby Dental Supply, LLCIMTECPROVISAPATTERSON

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, RESIN137
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING89
EBIResin, Denture, Relining, Repairing, Rebasing36
KLEAGENT, TOOTH BONDING, RESIN3
KOJAIRBRUSH2
NDPAccessories, Implant, Dental, Endosseous2

GMDN & GCC registration

  • GMDN code 17609 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 100% · 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

Weight (Pound) · 29Weight (Gram) · 11Total Volume (Fluid Ounce) · 10Total Volume (Milliliter) · 10Weight (Kilogram) · 7Total Volume (Gallon) · 1

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

How many denture reliner, hard products are registered in the US?

234 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Denture reliner, hard", from 12 companies. The largest labeler is 3M Deutschland Gmbh with 59% of records.

Which FDA product codes apply?

EBF (MATERIAL, TOOTH SHADE, RESIN), EBI (RESIN, DENTURE, RELINING, REPAIRING, REBASING), EBI (Resin, Denture, Relining, Repairing, Rebasing), 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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