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.
Summary
Osstell's Reusable SmartPeg is filed under EKX, AC-powered direct drive handpieces. The device name doesn't obviously match that code name, and the record doesn't explain the fit.
Class I, 21 CFR 872.4200. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Osstell filed from Goteborg, Sweden. Review took 88 calendar days (June 12 to September 8, 2026).
Clearance details
- Applicant
- Osstell AB
- Product code
- Product 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
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