Manufacturer registered with FDA

Reliance Dental Mfg., LLC

Alsip, IL, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator10048563ManufacturerRepacker / relabeler
Device types listed
4
Brands and models
4
510(k) clearances
21985–1987
Markets registered in
510 registrations outside the US
Establishments
1United States
1985: 11987: 119801990200020102020

510(k) clearances per year, 1980–2026

Registered in 5 markets

Where regulators' registries name Reliance Dental Mfg., LLC as the manufacturer or the registration holder of a device.

All markets
United States: 4 device types listedSouth Korea: 6 registrationsBrazil: 2 registrationsIsrael: 1 registrationsPeru: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerReliance Dental Mfg., LLC2 clearances1985–1987Below
South KoreaMFDSManufacturerReliance Dental Mfg., Co.Reliance Dental Mfg. Co. · Reliance Dental mfg., Co62000–2015Pure Global AI
BrazilANVISAManufacturerRELIANCE DENTAL MFG., CO.22007–2015Pure Global AI
IsraelAMARManufacturerRELIANCE DENTAL MFG.CO1—Pure Global AI
PeruDIGEMIDManufacturerRELIANCE DENTAL MFG, CO.12023–2023Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Reliance Dental Mfg., LLC currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Resin Impression Tray MaterialEBH · Class 1Impression traysLister
Duralay, Duralay Crown and Bridge, Duralay II, Duraseal, Durabase, Durabase Soft, Duraliner II, Duratray
2015
Rebasing Repairing Relining Denture ResinEBI · Class 2Denture resins & teethMaker
DuraConditioner, Dura Rely-A-Soft
2017
Preformed Impression TrayEHY · Class 1Impression traysLister
Trays, Perforated Impression
2015
Root Canal PostELR · Class 1Root canal filling materialsLister
Duralay Plastic Pins
2017

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Reliance Dental Mfg., LLC as the applicant.

Decided510(k)DeviceDevice type
19 Feb 1987K870148DURA ORTHO ACRYLICEBI Rebasing Repairing Relining Denture Resin
23 Sep 1985K852741DURA CONDITIONEREBI Rebasing Repairing Relining Denture Resin

Registered establishments

EstablishmentLocationWhat it does
RELIANCE DENTAL MFG., LLCFDA reg. 1415367Alsip, IL, United StatesManufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10048563). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.