REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS— 510(k) K892937

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K892937 for REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS, Substantially Equivalent on 1989-06-22. Applicant: Dentsply Intl..

Clearance details

Applicant: Dentsply Intl.
Product code: Code JDZ
Advisory panel: Orthopedic
Date received: 1989-04-21
Decision date: 1989-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

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Adverse events under product code JDZ

product code JDZ

Malfunction: 461
Total: 461

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.