Reusable SmartPeg— 510(k) K261987
Substantially EquivalentOsstell AB
FDA 510(k) clearance K261987 for Reusable SmartPeg, Substantially Equivalent on 2026-09-08. Applicant: Osstell AB. Device class: 1.
Clearance details
- Applicant
- Osstell AB
- Product code
- Code EKX
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goteborg, SE
Recent devices under product code EKX
view allMore clearances from Osstell AB
view allData sourced from openFDA. This site is unofficial and independent of the FDA.