SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24— 510(k) K060376

Substantially Equivalent

Simpler Implant, Inc.

FDA 510(k) clearance K060376 for SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24, Substantially Equivalent on 2006-04-25. Applicant: Simpler Implant, Inc..

Clearance details

Applicant: Simpler Implant, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 2006-02-14
Decision date: 2006-04-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Vancouver, Bc, CA

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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.