OrthoEasy Pal; OrthoEasy Pal Long Neck— 510(k) K260268
Substantially EquivalentBernhard 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.
Summary
Bernhard Förster's record covers two items, OrthoEasy Pal and OrthoEasy Pal Long Neck. The record lists one product code for both: OAT, orthodontic endosseous implants.
Class II, 21 CFR 872.3640. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Bernhard Förster filed from Pforzheim, Germany. Review took 111 calendar days (January 28 to May 19, 2026).
Clearance details
- Applicant
- Bernhard Förster GmbH (Bernhard Foerster Ltd.)
- Product code
- Product code OAT
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pforzheim, DE
Recent devices under product code OAT
view allAdverse events under product code OAT
product code OAT- Injury
- 355
- Total
- 355
Source: openFDA MAUDE database, through . 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.