THERMOFORM SHEET MATERIALS AND ACCESSORIES— 510(k) K072522

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..

Clearance details

Applicant
Dentsply International, Inc.
Product code
Code MQC
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
York, PA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MQC

product code MQC
Injury
377
Total
377

Source: openFDA MAUDE database, through . 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.