PREMIUM Implant Systems SHELTA Implant Systems— 510(k) K161989
Substantially EquivalentSweden & Martina S.P.A.
FDA 510(k) clearance K161989 for PREMIUM Implant Systems SHELTA Implant Systems, Substantially Equivalent on 2018-02-01. Applicant: Sweden & Martina S.P.A..
Clearance details
- Applicant
- Sweden & Martina S.P.A.
- Product code
- Code NHA
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Due Carrare, IT
Adverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
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.