Cleared Traditional

K242072 - CeraRoot TL Implant System (TL)

K242072 is an FDA 510(k) clearance for CeraRoot TL Implant System (TL), manufactured by Ceraroot SL. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K242072 · Ceraroot SL · Dental device
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May 2025
Decision
302d
Days
Class 2
Risk

K242072 is an FDA 510(k) clearance for the CeraRoot TL Implant System (TL). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Ceraroot SL (Les Franqueses Del Valles, ES). The FDA issued a Cleared decision on May 14, 2025 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ceraroot SL devices

FDA 510(k) Submission Details - K242072

510(k) Number K242072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2024
Decision Date May 14, 2025
Days to Decision 302 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 127d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 766
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