510(k) clearance
Reusable SmartPeg
- 510(k) number
- K261987
- Applicant
- Osstell AB
- Decision date
- Sep 8, 2026
- Date received
- Jun 12, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- EKX
- Device type
- Handpiece, Direct Drive, Ac-Powered
- Device class
- Class I
- Regulation
- 21 CFR 872.4200
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Goteborg, SE