Reusable SmartPeg
FDA 510(k) K261987 · Osstell AB
510(k) numberK261987
Submission
- Device name
- Reusable SmartPeg
- Applicant
- Osstell AB
Goteborg, SE - Received
- June 12, 2026
- Decision date
- September 8, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
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| K222688 | The TrustEKX · Traditional | Genoss Co., Ltd. | 08/09/2024SE |
| K233865 | X-Smart Pro; X-Smart Pro+EKX · Traditional | Dentsply Sirona, Inc. | 07/24/2024SE |
| K232551 | EM-07 Cordless Endo MotorEKX · Traditional | Forum Engineering Technologies (96) , Ltd. | 07/09/2024SE |
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoitEKX · Traditional | Micro-Nx Co., Ltd. | 11/09/2023SE |
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Questions and answers
When was Reusable SmartPeg cleared by the FDA?
Reusable SmartPeg (K261987) received a 510(k) decision of Substantially Equivalent on September 8, 2026, 88 days after the submission was received.
What is the product code of K261987?
The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.