SERIES I AND II IMPLANTS— 510(k) K882226

Substantially Equivalent

Saber Technology, Inc.

FDA 510(k) clearance K882226 for SERIES I AND II IMPLANTS, Substantially Equivalent on 1988-08-29. Applicant: Saber Technology, Inc..

Clearance details

Applicant: Saber Technology, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 1988-05-26
Decision date: 1988-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, 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.