UltraPrint-Dental Denture UV— 510(k) K253324

Substantially Equivalent

Guangzhou Heygears IMC., Inc.

FDA 510(k) clearance K253324 for UltraPrint-Dental Denture UV, Substantially Equivalent on 2025-11-20. Applicant: Guangzhou Heygears IMC., Inc..

Clearance details

Applicant: Guangzhou Heygears IMC., Inc.
Product code: Code EBI
Advisory panel: Dental
Date received: 2025-09-30
Decision date: 2025-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

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.