Manufacturer registered with FDA

Wire and Cable Specialties Inc

Coatesville, PA, United States. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10042083Contract manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
414 registrations outside the US
Establishments
1United States

Registered in 4 markets

Where regulators' registries name Wire and Cable Specialties Inc as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedColombia: 8 registrationsCosta Rica: 5 registrationsSouth Korea: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerWire and Cable Specialties Inc1 device types—Below
ColombiaINVIMAManufacturerWIRE AND CABLE SPECIALTIES, INC8—Pure Global AI
Costa RicaMinisterio de SaludManufacturerWire and Cable Specialties, Inc5—Pure Global AI
South KoreaMFDSManufacturerWire and Cable Specialties, Inc.12020–2020Pure 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 Wire and Cable Specialties Inc currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Orthodontic WireDZC · Class 1Orthodontic wires & bandsMaker
Multiple - Industry Generic Names
2012

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

Registered establishments

EstablishmentLocationWhat it does
Wire and Cable Specialties, Inc.FDA reg. 1000379569Coatesville, PA, United StatesContract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10042083). 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.