Dental Device Guide
Add your company

Manufacturer registered with FDA

Avalign Technologies

Rosemont, IL, United States. Lists 25 dental device types with FDA across 3 registered establishments.

FDA owner/operator10051835Contract manufacturerManufacturerRepacker / relabeler
Device types listed
25
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
1498 registrations outside the US
Establishments
3Germany, United States

Registered in 14 markets

Where regulators' registries name Avalign Technologies as the manufacturer or the registration holder of a device.

All markets
United States: 25 device types listedUnited Kingdom: 27 registrationsAustralia: 25 registrationsEuropean Union: 16 registrationsCanada: 11 registrationsSouth Korea: 6 registrationsIsrael: 5 registrationsTaiwan: 2 registrationsBrazil: 1 registrationsColombia: 1 registrationsCosta Rica: 1 registrationsHong Kong: 1 registrationsSaudi Arabia: 1 registrationsSerbia: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerAvalign Technologies25 device types—Below
United KingdomMHRAManufacturerAvalign Technologies, Inc.27—Pure Global AI
AustraliaTGAManufacturerAvalign Technologies Inc252018–2026Pure Global AI
European UnionEUDAMEDManufacturerAvalign Technologies Inc.16—Pure Global AI
CanadaHealth CanadaRegistration holderAVALIGN TECHNOLOGIES112022–2023Pure Global AI
South KoreaMFDSManufacturerAVALIGN TECHNOLOGIESAvalign Technologies, Inc. · Instrumed GmbH, dba Avalign German Specialty Instruments · +162014–2025Pure Global AI
IsraelAMARManufacturerAvalign Technologies, Inc.AVALIGN TECHNOLOGIES INC. · Avalign Technologies Inc · +15—Pure Global AI
TaiwanTFDAManufacturerAVALIGN TECHNOLOGIESMILLENNIUM SURGICAL CORP22016–2019Pure Global AI
BrazilANVISAManufacturerAVALIGN TECHNOLOGIES12019–2019Pure Global AI
ColombiaINVIMAManufacturerAVALIGN TECHNOLOGIES1—Pure Global AI
Costa RicaMinisterio de SaludManufacturerAvalign Technologies1—Pure Global AI
Hong KongMDDManufacturerAvalign Technologies, Inc.12026–2026Pure Global AI
Saudi ArabiaSFDAManufacturerAvalign Technologies, Inc.1—Pure Global AI
SerbiaALIMSManufacturerAvalign Technologies, inc.12024–2024Pure 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 Avalign Technologies currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Surgical Tooth Extractor ForcepsEMG · Class 1Dental hand instrumentsMaker—2016
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsMaker—2016
Surgical Osteotome ChiselEMM · Class 1Dental hand instrumentsMaker—2016
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker—2016
Mouth MirrorEAX · Class 1Dental hand instrumentsMaker—2016
Orthodontic Ligature Tucking InstrumentECP · Class 1Dental hand instrumentsLister—2019
Dental Dressing ForcepsEFL · Class 1Dental hand instrumentsMaker—2016
Preformed BarEHO · Class 1—Maker—2016
All Types RetractorEIG · Class 1Dental hand instrumentsMaker—2016
Cartridge SyringeEJI · Class 2Dental needles & syringesLister—2018
Operative PliersEJY · Class 1Dental hand instrumentsMaker—2016
Endodontic CuretteEKT · Class 1Dental hand instrumentsMaker—2016
Surgical Rongeur ForcepsEMH · Class 1Dental hand instrumentsMaker—2016
Surgical Bone FileEMI · Class 1Dental hand instrumentsMaker—2016
Intraoral Wire Lock and LigatureDYX · Class 2—Lister—2018
Orthodontic Band PusherECS · Class 1Dental hand instrumentsLister—2018
Dental Instrument Depth GaugeEIL · Class 1Dental hand instrumentsMaker—2016
Periodontic ProbeEIX · Class 1Dental hand instrumentsLister—2016
Dental Plastic Filling InstrumentEIY · Class 1Dental hand instrumentsLister—2018
Dental Instrument HandleEJB · Class 1Dental hand instrumentsMaker—2016
Operative Cutting InstrumentEKD · Class 1Dental hand instrumentsMaker—2016
Operative Amalgam and Foil CondenserEKG · Class 1Dental hand instrumentsLister—2018
Dental Surgical CuretteEMK · Class 1Dental hand instrumentsMaker—2016
Surgical Bone ChiselEML · Class 1Dental hand instrumentsMaker—2016
Orthodontic PlierJEX · Class 1Dental hand instrumentsLister—2018

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

Also lists devices cleared under other names

Avalign Technologies lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Miltex, Inc. (1), KLS Martin SE & Co. KG (1).

Decided510(k)DeviceApplicantDevice type
9 Mar 2009K083796MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHTMiltex, Inc.EJI Cartridge Syringe
30 Jun 2006K061271ERCH ARCH BAR, MODEL 38-690-00KLS Martin SE & Co. KGDYX Intraoral Wire Lock and Ligature

Registered establishments

EstablishmentLocationWhat it does
Instrumed GmbH dba Avalign German Specialty InstrumentsFDA reg. 8010372TUTTLINGEN Baden-Wurttemberg, GermanyManufacturer
Instrumed International Inc dba Avalign German Specialty InstrumentsFDA reg. 1421101SCHAUMBURG, IL, United StatesContract manufacturer, Repacker / relabeler
MILLENNIUM SURGICAL CORPFDA reg. 3004215117Schaumburg, IL, United StatesRepacker / relabeler

Other names on FDA records

Instrumed GmbH, dba Avalign German Specialty Instruments · Millennium Surgical Corp. · Instrumed International Inc dba Avalign German Specialty Instruments

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10051835). 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.