The following data is part of a premarket notification filed by St. George Technology, Inc. with the FDA for Excel Formula Heat-auto Cure Dent Base/repair/ortho.
| Device ID | K934019 |
| 510k Number | K934019 |
| Device Name: | EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | ST. GEORGE TECHNOLOGY, INC. P.O. BOX 1586 York, PA 17405 -0586 |
| Contact | Vernon Watkins |
| Correspondent | Vernon Watkins ST. GEORGE TECHNOLOGY, INC. P.O. BOX 1586 York, PA 17405 -0586 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-17 |
| Decision Date | 1994-01-18 |