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510(k) K242072

CeraRoot TL Implant System (TL) by Ceraroot SL — Product Code DZE

K242072 is an FDA 510(k) premarket notification submitted by Ceraroot SL for the device "CeraRoot TL Implant System (TL)". The FDA issued a decision of Substantially Equivalent on May 14, 2025. 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
May 14, 2025
Date Received
July 16, 2024
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

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FDA data resources