Data / Medical devices / United States / ST. George Technology, Inc.
ST. George Technology, Inc.: FDA-registered device maker in Wilmington, NC, United States, 4 510(k) clearances
ST. George Technology, Inc. is registered with the FDA (registration 2530024) in Wilmington, NC, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 10, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2530024
- FEI number
- 1000161170
- Address
- 210 N. Green Meadows Drive, Wilmington, NC, United States, 28405
- Owner or operator
- ST. GEORGE TECHNOLOGY, INC. (9008006)
- Roles
- Specification developer
- First device listed
- April 8, 2013
- Registered through
- 2026
- Brand names listed
- Excel Formula Dental Waxes, Excel Formula Heat Cure Denture Base Material, Excel Formula Orthodontic Denture Base Material, Excel Formula Pourable Denture Base Material, Excel Formula Repair Denture Base Material, Excel Formula Ultra Hi Impact Heat CureDenture Base Material, Excel Formula Waxes, Paladon Impact
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Specification developer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 10, 2000 | K992176 | EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL | EBI | Substantially Equivalent | St. George Technology, Inc. | accessdata.fda.gov |
| February 18, 1999 | K984483 | A-SOFT RELINER | EBI | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
| February 2, 1995 | K945711 | EXCEL-P FORMULA AUTO-CURE DENTURE BASE | EBI | Substantially Equivalent | St. George Technology, Inc. | accessdata.fda.gov |
| January 18, 1994 | K934019 | EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO | EBI | Substantially Equivalent | St. George Technology, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 10, 2000. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.