EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO— 510(k) K934019
Substantially EquivalentSt. George Technology, Inc.
FDA 510(k) clearance K934019 for EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO, Substantially Equivalent on 1994-01-18. Applicant: St. George Technology, Inc..
Clearance details
- Applicant
- St. George Technology, Inc.
- Product code
- Code EBI
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- York, PA, US
Adverse events under product code EBI
product code EBI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.