510(k) K243356
K243356 is an FDA 510(k) premarket notification submitted by Asiga Pty, Ltd. for the device "Asiga DentaBASE". The FDA issued a decision of Substantially Equivalent on April 11, 2025. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Asiga Pty, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2025
- Date Received
- October 29, 2024
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resin, Denture, Relining, Repairing, Rebasing
- Device Class
- Class II
- Regulation Number
- 872.3760
- Review Panel
- DE
- Submission Type