Not currently registered with FDA under this name
Miltex, Inc.
York, PA, United States. Named as applicant on 14 dental 510(k) clearances between 1982 and 2009. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 141982–2009
- Markets registered in
- 5122 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 5 markets
Where regulators' registries name Miltex, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Miltex, Inc. | 14 clearances | 1982–2009 | Below |
| South Korea | MFDS | Manufacturer | Miltex, IncMiltex, Inc. · MILTEX GmbH · +2 | 102 | 1999–2010 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MILTEX, INC. | 18 | 2005–2021 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MILTEX INCORPORATED | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Miltex Inc. | 1 | — | 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
510(k) clearances
Clearances on which FDA names Miltex, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Dec 2009 | K092855 | MILTEX MEMBRANE TACK KIT | DZL Intraosseous Fixation Screw |
| 9 Mar 2009 | K083796 | MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT | EJI Cartridge Syringe |
| 24 Nov 1982 | K823326 | DENTAL INSTRUMENTS - CUTTING INSTRUMENT | ELA Calculus Removal Hand Instrument |
| 24 Nov 1982 | K823325 | DENTAL INSTRUMENTS - SURGICAL FORCEPS | EMG Surgical Tooth Extractor Forceps |
| 24 Nov 1982 | K823324 | DENTAL INSTRUMENTS - PROBES | EIX Periodontic Probe |
| 24 Nov 1982 | K823323 | DENTAL INSTRUMENTS - PLASTIC INSTRUMENTS | EIY Dental Plastic Filling Instrument |
| 24 Nov 1982 | K823322 | DENTAL INSTRUMENTS - PLUGGERS | EKG Operative Amalgam and Foil Condenser |
| 24 Nov 1982 | K823321 | DENTAL INSTRUMENTS - CARVER | EKH Operative Dental Amalgam Carver |
| 24 Nov 1982 | K823320 | DENTAL INSTRUMENTS - BONE CHISELS | EML Surgical Bone Chisel |
| 24 Nov 1982 | K823319 | DENTAL INSTRUMENTS - SCALERS | EMS Periodontic Curette |
| 24 Nov 1982 | K823318 | DENTAL INSTRUMENTS - EXCAVATORS | EKS Endodontic Pulp Canal File |
| 24 Nov 1982 | K823316 | DENTAL INSTRUMENTS - FILES | EKS Endodontic Pulp Canal File |
| 24 Nov 1982 | K823315 | DENTAL INSTRUMENTS - KNIVES | EJZ Operative Margin Finishing Knife |
| 24 Nov 1982 | K823314 | DENTAL INSTRUMENTS | EJL Dental Bur |
Some of these clearances are listed with FDA today by another company: Helmut Zepf Medizintechnik GmbH (1), Avalign Technologies (1), Integra LifeSciences Corporation (1).
Sources
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 of the most recent filing, which can be a US agent.