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510(k) K242103

TRIOS Ready Tip by 3Shape TRIOS A/S — Product Code NBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2025
Date Received
July 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Fluorescence Caries Detection
Device Class
Class II
Regulation Number
872.1745
Review Panel
DE
Submission Type

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  • K171007 — Fluorescence Mode (May 3, 2018)
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