510(k) K223798— Glidewell TuffSplint Appliance Resin

Substantially Equivalent

Prismatik Dentalcraft, Inc.

Clearance details

Applicant: Prismatik Dentalcraft, Inc.
Product code: Code MQC
Advisory panel: Unknown
Date received: 2022-12-19
Decision date: 2023-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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.