510(k) K192839
K192839 is an FDA 510(k) premarket notification submitted by D.S.P Industrial Eireli for the device "DSP Implant System". The FDA issued a decision of Substantially Equivalent on Feb 11, 2021. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 11, 2021
- Date Received
- Sep 26, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type
- 510(k)