FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
OrthoEasy Pal; OrthoEasy Pal Long Neck
K Number: K260268
·
Decision May 19, 2026
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
51
Applicant Total
1
Review Days
111
Basic Information
- Device Name
- OrthoEasy Pal; OrthoEasy Pal Long Neck
- K Number
- K260268
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bernhard Förster GmbH (Bernhard Foerster Ltd.)
- Date Received
- January 28, 2026
- Decision Date
- May 19, 2026
- Product Code
- OAT
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OAT | Implant, Endosseous, Orthodontic | FDA class 2 | Dental |
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