TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND— 510(k) K000996

Name: FDA 510(k) clearance K000996
Creator: U.S. Food and Drug Administration
Published: 2000-06-16

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K000996 for TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND, Substantially Equivalent on 2000-06-16. Applicant: Dentsply Intl.. Device class: 1.

Clearance details

Applicant: Dentsply Intl.
Product code: Code EFT
Device class: Class 1
Regulation: 21 CFR 872.3520
Advisory panel: Dental
Date received: 2000-03-28
Decision date: 2000-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EFT

product code EFT

Death: 8
Injury: 267
Total: 275

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.