Consulting Wallah › Device Explorer › Dental › Denture reliner, elastic, short-term
Device Explorer · FDA GUDID · GMDN 34769

Denture reliner, elastic, short-term

A denture relining material intended to be applied by a dentist or dental laboratory technician as a temporary coating or lining on the base or tissue-contact surface of a denture and which has elastic properties after setting. Denture relining is defined as a

US‑registered devices98in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription23%Rx‑only share
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Share of device records

Protech Professional Products Inc7577%
Gc America Inc.1616%
Septodont, Inc33%
Henry Schein, Inc.33%
Tokuyama Dental Corporation11%

Top labelers

CompanyDevicesShare
Protech Professional Products Inc7577%
Gc America Inc.1616%
Septodont, Inc33%
Henry Schein, Inc.33%
Tokuyama Dental Corporation11%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Novocol EXACTON SOFT CHRSD RELINE PWD/LIQNovocol EXACTON CHAIRSIDE RELINE POWDER 100GNovocol EXACTON HARD CHRSD RELINE PWD/LIQSofreliner ToughProTech UBARD814UBAR87D0PermaLinerProTech Plus Hard Reline and Repair AcrylicMollosil Plus Glaze and CatalystMollosil Plus Adhesion PromoterMolosil Plus Cartridge OnlyMollosil Plus Full KitGC Reline ™COE-SOFT™COE-COMFORT™Henry Schein

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, Rebasing234
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING26

GMDN & GCC registration

  • GMDN code 34769 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 23% · 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 (Gram) · 9Total Volume (Fluid Ounce) · 2Total Volume (Milliliter) · 2

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

How many denture reliner, elastic, short-term products are registered in the US?

98 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Denture reliner, elastic, short-term", from 5 companies. The largest labeler is Protech Professional Products Inc with 77% of records.

Which FDA product codes apply?

EBI (Resin, Denture, Relining, Repairing, Rebasing), EBI (RESIN, DENTURE, RELINING, REPAIRING, REBASING)

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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