Dental LT Comfort Resin— 510(k) K232087

Substantially Equivalent

Formlabs Ohio, Inc.

FDA 510(k) clearance K232087 for Dental LT Comfort Resin, Substantially Equivalent on 2024-02-16. Applicant: Formlabs Ohio, Inc..

Clearance details

Applicant: Formlabs Ohio, Inc.
Product code: Code MQC
Advisory panel: Unknown
Date received: 2023-07-13
Decision date: 2024-02-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Millbury, OH, US

Download summary PDF View on FDA.gov ↗

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.