THERMOFORM SHEET MATERIALS AND ACCESSORIES— 510(k) K072522

Name: FDA 510(k) clearance K072522
Creator: U.S. Food and Drug Administration
Published: 2007-11-16

Substantially Equivalent

Dentsply International, Inc.

FDA 510(k) clearance K072522 for THERMOFORM SHEET MATERIALS AND ACCESSORIES, Substantially Equivalent on 2007-11-16. Applicant: Dentsply International, Inc.. Device class: Unclassified.

Clearance details

Applicant: Dentsply International, Inc.
Product code: Code MQC
Device class: Unclassified
Advisory panel: Unknown
Date received: 2007-09-07
Decision date: 2007-11-16
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 MQC

product code MQC

Injury: 377
Total: 377

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.