Clear Aligner (SCF-3348)— 510(k) K251454

Substantially Equivalent

Beame Medical Technology (Shenzhen) Limited

FDA 510(k) clearance K251454 for Clear Aligner (SCF-3348), Substantially Equivalent on 2026-01-07. Applicant: Beame Medical Technology (Shenzhen) Limited.

Clearance details

Applicant: Beame Medical Technology (Shenzhen) Limited
Product code: Code NXC
Advisory panel: Dental
Date received: 2025-05-12
Decision date: 2026-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code NXC

product code NXC

Injury: 15,206
Malfunction: 2,576
Other: 9
Total: 17,791

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.