Not currently registered with FDA under this name
Afp Imaging Corp.
Naples, FL, United States. Named as applicant on 7 dental 510(k) clearances between 1993 and 2012. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 71993–2012
- Markets registered in
- 23 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Afp Imaging Corp. 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 | Afp Imaging Corp. | 7 clearances | 1993–2012 | Below |
| South Korea | MFDS | Manufacturer | AFP Imaging CorporationAFP, IMAGING CORPORATION · AFP. IMAGING CORPORATION | 3 | 1998–2004 | 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 Afp Imaging Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Dec 2012 | K123419 | EVA SELECT DIGITAL DENTAL IMAGING SYSTEM | MUH Digital Extraoral Source X-Ray System |
| 18 Sep 2007 | K072357 | NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM | MUH Digital Extraoral Source X-Ray System |
| 30 Aug 2004 | K041120 | EV APAN DIGITAL, MODEL K1VSM2000 | MUH Digital Extraoral Source X-Ray System |
| 20 Mar 2003 | K030647 | EVA DIGITAL DENTAL X-RAY SYSTEM | EHD Extraoral with Timer X-Ray Unit |
| 7 Feb 2002 | K014144 | EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 | EBF Resin Tooth Shade Material |
| 16 Oct 2001 | K013176 | MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE | EHD Extraoral with Timer X-Ray Unit |
| 25 May 1993 | K930761 | IMAGE-X 70 INTRAORAL X-RAY SYSTEM | EAP Intraoral X-Ray Unit |
Some of these clearances are listed with FDA today by another company: SMK Imaging LLC (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.