Osstell Isq Implant Stability Meter
FDA 510(k) K082523 · Osstell AB
510(k) numberK082523
Submission
- Device name
- Osstell Isq Implant Stability Meter
- Applicant
- Osstell AB
Alexandria, VA, US - Received
- September 2, 2008
- Decision date
- September 26, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
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| K233865 | X-Smart Pro; X-Smart Pro+EKX · Traditional | Dentsply Sirona, Inc. | 07/24/2024SE |
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Questions and answers
When was Osstell Isq Implant Stability Meter cleared by the FDA?
Osstell Isq Implant Stability Meter (K082523) received a 510(k) decision of Substantially Equivalent on September 26, 2008, 24 days after the submission was received.
What is the product code of K082523?
The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.