PREMIUM, SHELTA Implant Systems— 510(k) K142242

Substantially Equivalent

Sweden & Martina S.P.A.

FDA 510(k) clearance K142242 for PREMIUM, SHELTA Implant Systems, Substantially Equivalent on 2015-02-02. Applicant: Sweden & Martina S.P.A..

Clearance details

Applicant: Sweden & Martina S.P.A.
Product code: Code DZE
Advisory panel: Dental
Date received: 2014-08-13
Decision date: 2015-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Due Carrare, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.