Dental Device Guide
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Manufacturer registered with FDA

Cardinal Health 200, LLC

Waukegan, IL, United States. Lists 20 dental device types with FDA across 8 registered establishments.

FDA owner/operator9028292ManufacturerRepacker / relabelerSpecification developer
Device types listed
20
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
163,587 registrations outside the US
Establishments
8Mexico, United States

Registered in 16 markets

Where regulators' registries name Cardinal Health 200, LLC as the manufacturer or the registration holder of a device.

All markets
United States: 20 device types listedColombia: 2,405 registrationsCanada: 405 registrationsCosta Rica: 227 registrationsSaudi Arabia: 140 registrationsBrazil: 92 registrationsTaiwan: 81 registrationsThailand: 80 registrationsSouth Korea: 61 registrationsIsrael: 50 registrationsAustralia: 23 registrationsChina: 16 registrationsEuropean Union: 2 registrationsHong Kong: 2 registrationsPeru: 2 registrationsUnited Kingdom: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerCardinal Health 200, LLC20 device types—Below
ColombiaINVIMARegistration holderCARDINAL HEALTH 200 LLCCARDINAL HEALTH 200, LLC · CARDINAL HEALTH, 200 LLC · +22,405—Pure Global AI
CanadaHealth CanadaRegistration holderCARDINAL HEALTHCARDINAL HEALTH, INC.4051998–2024Pure Global AI
Costa RicaMinisterio de SaludManufacturerCARDINAL HEALTH 200, LLCCardinal Health (Kenmex Medical Specialties) · Cardinal Health · +2227—Pure Global AI
Saudi ArabiaSFDAManufacturerCardinal Health 200, LLCCardinal Health · CARDINAL HEALTH 200 LLC · +1140—Pure Global AI
BrazilANVISAManufacturerCARDINAL HEALTH 200, LLCCARDINAL HEALTH · Cardinal Health 200, LLC · +1922010–2025Pure Global AI
TaiwanTFDAManufacturerCardinal Health 200, LLCCARDINAL HEALTH 200 LLC · CARDINAL HEALTH 200, INC. · +2812005–2026Pure Global AI
ThailandThai FDAManufacturerCARDINAL HEALTH 200, LLC80—Pure Global AI
South KoreaMFDSManufacturerCardinal HealthCardinal Health K.K. · Cardinal Health(Kenmex Medical Specialties)611999–2025Pure Global AI
IsraelAMARManufacturerCardinal Health 200 LLCCardinal Health 200, LLC · Cardinal health, 200 LLC · +250—Pure Global AI
AustraliaTGAManufacturerCardinal Health 200 LLC232011–2025Pure Global AI
ChinaNMPARegistration holder嘉德诺健康有限责任公司Cardinal Health 200, LLC嘉德诺健康有限责任公司 Cardinal Health 200, LLC · Cardinal Health 200, LLC 嘉德诺健康有限责任公司16—Pure Global AI
European UnionEUDAMEDManufacturerCardinal Health 200 LLC2—Pure Global AI
Hong KongMDDManufacturerCARDINAL HEALTH 200, LLCCardinal Health 200, LLC22025–2026Pure Global AI
PeruDIGEMIDManufacturerCARDINAL HEALTH 200 LLC22022–2022Pure Global AI
United KingdomMHRAManufacturerCardinal Health1—Pure 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 Cardinal Health 200, LLC currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Manual ToothbrushEFW · Class 1ToothbrushesLister—2013
Saliva Ejector MouthpieceDYN · Class 1—Maker—2004
Dental NeedleDZM · Class 1Dental needles & syringesMaker—1977
Denture Repair KitEBO · Class 2—Maker—2011
Oral Cavity EvacuatorEHZ · Class 1Suction & evacuation unitsMaker—2008
Irrigating Endodontic Periodontic SyringeEIC · Class 1Dental hand instrumentsMaker—1977
Dental Hygiene KitNXZ · Class 1—Maker—2011
Dental Prophylaxis KitNYC · Class 1Dental hand instrumentsMaker—2011
Endodontic KitNYD · Class 2—Maker—2011
Fixture Mount KitNYE · Class 1Implant instruments & surgical kitsMaker—2011
Gingival Retraction KitNYF · Class 1Dental hand instrumentsMaker—2011
Lapping Tool KitNYG · Class 1Dental hand instrumentsMaker—2011
Plaque Disclosing KitNYH · Class 2—Maker—2011
Restorative Instrument and Component TrayOFW · Class 2—Maker—2011
General Purpose Dental TrayOFX · Class 1—Maker—2011
Dental Implant Surgical TrayOFY · Class 1Implant instruments & surgical kitsMaker—2011
Oral Irrigation KitOGT · Class 1—Maker—2011
Oral Surgery TrayPWL · Class 1Dental hand instrumentsMaker—2018
Orthodontic Elastic BandECI · Class 1Orthodontic wires & bandsLister—2012
Roll CottonEFN · Class 1—Lister—2009

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
Cardinal HealthFDA reg. 1921846Hazelwood, MO, United StatesSpecification developer
Cardinal HealthFDA reg. 1017768DELAND, FL, United StatesManufacturer
Cardinal HealthFDA reg. 1915484Norfolk, NE, United StatesManufacturer
Cardinal Health (Kenmex Medical Specialties)FDA reg. 9612030TIJUANA Baja California, MexicoManufacturer
Cardinal Health 200, LLCFDA reg. 1423537Waukegan, IL, United StatesComplaint file establishment
Cardinal Health 200, LLCFDA reg. 3007329020El Paso, TX, United StatesManufacturer, Repacker / relabeler
Convertors de Mexico S. de R.L. de C.VFDA reg. 9616088CD.JUAREZ Chihuahua, MexicoManufacturer, Repacker / relabeler
Convertors de Mexico S. de R.L. de C.VFDA reg. 3018167761Ciudad Juarez Chihuahua, MexicoRepacker / relabeler

Other names on FDA records

Cardinal Health · Cardinal Health (Kenmex Medical Specialties) · Convertors de Mexico S. de R.L. de C.V

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9028292). 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.