Manufacturer registered with FDA
St. George Technology, Inc.
Wilmington, NC, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 9
- 510(k) clearances
- 41994–2003
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 3 markets
Where regulators' registries name St. George Technology, 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 | Manufacturer | St. George Technology, Inc. | 4 clearances | 1994–2003 | Below |
| South Korea | MFDS | Manufacturer | St. George Technology, Inc | 2 | 2014–2014 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | St George Technology Ltd | 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
Devices listed with FDA
What St. George Technology, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Excel Formula Heat Cure Denture Base MaterialExcel Formula Heat-Cured Denture Base MaterialExcel Formula Orthodontic Denture Base MaterialExcel Formula Pourable Denture Base MaterialExcel Formula Repair Denture Base MaterialExcel Formula Ultra Hi Impact Heat CureDenture Base MaterialExcel Formula WaxesPaladon Impact | 2016 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Excel Formula Dental Waxes | 2013 |
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 St. George Technology, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Feb 2003 | K023953 | ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 10 Feb 2000 | K992176 | EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL | EBI Rebasing Repairing Relining Denture Resin |
| 2 Feb 1995 | K945711 | EXCEL-P FORMULA AUTO-CURE DENTURE BASE | EBI Rebasing Repairing Relining Denture Resin |
| 18 Jan 1994 | K934019 | EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO | EBI Rebasing Repairing Relining Denture Resin |
Some of these clearances are listed with FDA today by another company: Garreco, LLC. (3).
Also lists devices cleared under other names
St. George Technology, Inc. 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: S & C Polymer GmbH (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Feb 1999 | K984483 | A-SOFT RELINER | S & C Polymer GmbH | EBI Rebasing Repairing Relining Denture Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ST. GEORGE TECHNOLOGY, INC.FDA reg. 2530024 | Wilmington, NC, United States | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9008006). 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.