Manufacturer registered with FDA
Midmark Corporation
Versailles, OH, United States. Lists 7 dental device types with FDA across 1 registered establishment, and holds 7 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 16
- 510(k) clearances
- 72000–2025
- Markets registered in
- 12276 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 12 markets
Where regulators' registries name Midmark Corporation as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Midmark Corporation | 7 clearances | 2000–2025 | Below |
| Canada | Health Canada | Registration holder | MIDMARK CORPORATIONMIDMARK | 159 | 1999–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Midmark CorpMidmark Corporation | 33 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | MIDMARK CORPORATIONMIDMARK CORP. · Midmark Corp. | 27 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Midmark CorporationMIDMARK CORPORATION · Midmark corporation | 22 | 1999–2015 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MIDMARK CORPORATIONMidmark Corp. | 17 | 2005–2018 | Pure Global AI |
| Colombia | INVIMA | Registration holder | MIDMARK CORP.MIDMARK CORPORATION | 5 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Midmark Corporation | 4 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Midmark Corporation | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Midmark Corp | 2 | 2014–2014 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Midmark Corporation | 2 | 2009–2016 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Midmark Corporation | 2 | — | 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 Midmark Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | MIDMARKMidmark Dental Delivery System | 2007 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | Midmark Intraoral Digital SensorPROGENY IMAGING SOFTWARE | 2009 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | MIDMARK | 1999 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | Midmark Cuspidor | 2026 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | Preva, Extraoral X-Ray System | 2009 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | ClassicSeriesMidmark Smart Air CompressorMidmark Smart G VacuumPowerAirPowerMaxPowerVacPowerVac G | 2004 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | ElevanceMidmark | 2010 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Midmark Corporation as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Nov 2025 | K251626 | Midmark Dental Delivery System | EIA Operative Dental Unit |
| 6 Aug 2020 | K201667 | Midmark Extraoral Imaging System (EOIS) | OAS Dental Computed Tomography X-Ray |
| 7 Jan 2013 | K122643 | VANTAGE MODEL V5000, V5100, V5000C, V5100C | MUH Digital Extraoral Source X-Ray System |
| 24 Aug 2012 | K120239 | ELEVANCE | EIA Operative Dental Unit |
| 22 Nov 2011 | K112380 | CLEARVISION | MUH Digital Extraoral Source X-Ray System |
| 20 Jul 2009 | K091866 | PROGENY VANTAGE PANORAMIC X-RAY SYSTEM | MUH Digital Extraoral Source X-Ray System |
| 18 Oct 2000 | K003090 | MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM | EIA Operative Dental Unit |
Also lists devices cleared under other names
Midmark Corporation 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: Progeny, Inc. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 26 Apr 2007 | K070664 | PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8). | Progeny, Inc. | MUH Digital Extraoral Source X-Ray System |
| 13 Dec 2004 | K043092 | PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 | Progeny, Inc. | EHD Extraoral with Timer X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MIDMARK CORPORATIONFDA reg. 1523530 | Versailles, OH, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9915004). 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.