OrthoFit Aligner (OrthoFit Aligner A2)— 510(k) K262433

Name: FDA 510(k) clearance K262433
Creator: U.S. Food and Drug Administration
Published: 2026-10-13

Substantially Equivalent

Spident Co., Ltd.

FDA 510(k) clearance K262433 for OrthoFit Aligner (OrthoFit Aligner A2), Substantially Equivalent on 2026-10-13. Applicant: Spident Co., Ltd.. Device class: 2.

Clearance details

Applicant: Spident Co., Ltd.
Product code: Product code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 2026-07-16
Decision date: 2026-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Incheon, KR

Download summary PDF View on FDA.gov ↗

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