Manufacturer registered with FDA
Wolf X-Ray Corp
Battleboro, NC, United States. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 16
- 510(k) clearances
- 0as applicant
- Markets registered in
- 847 registrations outside the US
- Establishments
- 1United States
Registered in 8 markets
Where regulators' registries name Wolf X-Ray 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 | Manufacturer | Wolf X-Ray Corp | 4 device types | — | Below |
| Saudi Arabia | SFDA | Manufacturer | Wolf X-Ray Corp | 27 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | WOLF X-RAY CORPORATION | 8 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Wolf X-Ray CorporationWolf X-ray Corporation | 4 | 2001–2009 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | WOLF X-RAY CORPORATION | 3 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Wolf X-Ray Corporation | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | WOLF X-RAY CORPWolf X-Ray Corporation | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Wolf X-Ray Corp | 1 | 2025–2025 | 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 Wolf X-Ray Corp currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Articulation PaperEFH · Class 1 | — | Maker | EXPOSURE ARTICULATING FILMEXPOSURE DOUBLE ARTICULATING FILM | 2013 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | All-Bite, Digi LoopsBite Block BaggiesDispozaSleevesEndodontic PositionerSafe 'n' Sure 3V PSP Envelopes Sizes 0, 1, 2Safe 'n' Sure Deluxe and Econo PSP Envelopes Sizes 0, 1, 2, 3Safe 'n' Sure OPT PSP Envelopes Sizes 0, 1, 2, 3Sensibles, Bite Blocks, RAPiDSMART Positioning SystemSnuggies, Comfees 2 moreSticky Bites, SUPAs, Stickems, Loop EZ, Cushies, Deluxe CushiesUni-Verse-All Positioner | 2007 |
| X-Ray Beam AlignerEHA · Class 1 | — | Lister | Bullseye Alignment Device | 2007 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Perfect Shape | 2026 |
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
| Establishment | Location | What it does |
|---|---|---|
| WOLF X-RAY CORPFDA reg. 2431224 | Battleboro, NC, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2431224). 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.