OrthoEasy Pal; OrthoEasy Pal Long Neck— 510(k) K260268

Name: FDA 510(k) clearance K260268
Creator: U.S. Food and Drug Administration
Published: 2026-05-19

Substantially Equivalent

Bernhard Förster GmbH (Bernhard Foerster Ltd.)

FDA 510(k) clearance K260268 for OrthoEasy Pal; OrthoEasy Pal Long Neck, Substantially Equivalent on 2026-05-19. Applicant: Bernhard Förster GmbH (Bernhard Foerster Ltd.). Device class: 2.

Clearance details

Applicant: Bernhard Förster GmbH (Bernhard Foerster Ltd.)
Product code: Code OAT
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2026-01-28
Decision date: 2026-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pforzheim, DE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OAT

product code OAT

Injury: 355
Total: 355

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.