K970992

Substantially Equivalent

PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS

Applicant: Premier Dental Products Co.
Product code: GEH
Advisory panel: General, Plastic Surgery
Date received: 1997-03-19
Decision date: 1997-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: King Of Prussia, PA, US

Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.