CMW CEMENT PRESSURISATION SYSTEM— 510(k) K897134

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K897134 for CMW CEMENT PRESSURISATION SYSTEM, Substantially Equivalent on 1990-03-02. Applicant: Dentsply Intl..

Clearance details

Applicant: Dentsply Intl.
Product code: Code KIH
Advisory panel: Orthopedic
Date received: 1989-12-27
Decision date: 1990-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

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Adverse events under product code KIH

product code KIH

Death: 3
Total: 3

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.