Manufacturer registered with FDA

Celestica de Monterrey S.A. de C.V.

Apodaca, Mexico. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10054863Contract manufacturer
Device types listed
1
Brands and models
5
510(k) clearances
0as applicant
Markets registered in
536 registrations outside the US
Establishments
1Mexico

Registered in 5 markets

Where regulators' registries name Celestica de Monterrey S.A. de C.V. as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedColombia: 13 registrationsSouth Korea: 10 registrationsCosta Rica: 7 registrationsTaiwan: 6 registrations
RegisteredHome: MexicoOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerCelestica de Monterrey S.A. de C.V.1 device types—Below
ColombiaINVIMAManufacturerCELESTICA DE MONTERREY S.A. DE C.V.13—Pure Global AI
South KoreaMFDSManufacturerCelestica de Monterrey SA de CV102011–2025Pure Global AI
Costa RicaMinisterio de SaludManufacturerCelestica de Monterrey S.A de C.V.7—Pure Global AI
TaiwanTFDAManufacturerCelestica de Monterrey S.A. de C.V.Celestica de Monterrey SA de CV62005–2025Pure 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 Celestica de Monterrey S.A. de C.V. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Intraosseous Fixation ScrewDZL · Class 2Maxillofacial plates & screwsMaker
JGRKNT 1MM MINI STEP DRILL1mm JuggerKnot™ Mini 2-0 w/ Tapered Needles1mm JuggerKnot™ Mini 2-0 w/ Tapered Needles Multi Pack1mm JuggerKnot™ Mini 3-0 w/ Tapered Needles1mm JuggerKnot™ Mini 3-0 w/ Tapered Needles Multi Pack
2020

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
CELESTICA de MONTERREY S.A. de C.V.FDA reg. 3003139373Apodaca Nuevo Leon, MexicoContract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10054863). 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.