PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS— 510(k) K970992
Substantially EquivalentPremier Dental Products Co.
FDA 510(k) clearance K970992 for PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS, Substantially Equivalent on 1997-06-17. Applicant: Premier Dental Products Co.. Device class: 2.
Clearance details
- Applicant
- Premier Dental Products Co.
- Product code
- Product code GEH
- Device class
- Class 2
- Regulation
- 21 CFR 878.4350
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- King Of Prussia, PA, US
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More clearances from Premier Dental Products Co.
view allAdverse events under product code GEH
product code GEH- Death
- 25
- Injury
- 351
- Malfunction
- 901
- Total
- 1,277
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.