TRUBYTE DENTURE BASE RESIN SYSTEM— 510(k) K011560

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K011560 for TRUBYTE DENTURE BASE RESIN SYSTEM, Substantially Equivalent on 2001-07-12. Applicant: Dentsply Intl..

Clearance details

Applicant: Dentsply Intl.
Product code: Code EBI
Advisory panel: Dental
Date received: 2001-05-21
Decision date: 2001-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

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Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

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.