MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK— 510(k) K033630

Substantially Equivalent

Rhein 83 Srl

FDA 510(k) clearance K033630 for MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK, Substantially Equivalent on 2004-04-21. Applicant: Rhein 83 Srl.

Clearance details

Applicant: Rhein 83 Srl
Product code: Code DZE
Advisory panel: Dental
Date received: 2003-11-17
Decision date: 2004-04-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Hoboken, NJ, US

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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.