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510(k) K243356

Asiga DentaBASE by Asiga Pty, Ltd. — Product Code EBI

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

Other clearances by Asiga Pty, Ltd.

  • K243370 — DentaTOOTH (May 5, 2025)

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