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Device Explorer · FDA GUDID · GMDN 17610

Denture reliner, soft, professional

A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is d

US‑registered devices300in commercial distribution
Companies20labelers on GUDID
Single‑use53%of device records
Sterile0%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Lang Dental Manufacturing Co., Inc.14548%
Gc America Inc.4515%
Harry J Bosworth Company289%
Keystone Industries248%
Parkell, Inc.83%
Kerr Corporation72%
The Myerson Company Limited62%
Garreco, Llc62%

Top labelers

CompanyDevicesShare
Lang Dental Manufacturing Co., Inc.14548%
Gc America Inc.4515%
Harry J Bosworth Company289%
Keystone Industries248%
Parkell, Inc.83%
Kerr Corporation72%
The Myerson Company Limited62%
Garreco, Llc62%
Karlin Dental Distributors Inc52%
Henry Schein, Inc.52%
Voco Gmbh41%
Zest Anchors, Llc41%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

flow.sil AssortmentBISICO SoftbaseUfi Gel SCPERMASOFTAxcent AcrylicsSoftLineCHAIRSIDEChairsideIMTECPearson Soft Life KitPearson Soft Life Standard PackageHydro-Cast®OTCMucoSoft®SUPER-SOFT™COE-SOFT™

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, Rebasing194
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING119
EMBZINC OXIDE EUGENOL5
NDPAccessories, Implant, Dental, Endosseous2
EFXPROTECTOR, SILICATE1
ELWMATERIAL, IMPRESSION1

GMDN & GCC registration

  • GMDN code 17610 · non‑implantable
  • Single‑use 53% · sterile 0% · Rx‑only 97% · 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) · 37Weight (Gram) · 18Weight (Pound) · 15Total Volume (Fluid Ounce) · 11Total Volume (Quart) · 10Weight (Kilogram) · 3

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

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

300 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Denture reliner, soft, professional", from 20 companies. The largest labeler is Lang Dental Manufacturing Co., Inc. with 48% of records.

Which FDA product codes apply?

EBI (Resin, Denture, Relining, Repairing, Rebasing), EBI (RESIN, DENTURE, RELINING, REPAIRING, REBASING), EMB (ZINC OXIDE EUGENOL), NDP (Accessories, Implant, Dental, Endosseous)

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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