Cleared Traditional

K232076 - Fibercure (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232076 · Lumendo AG · Dental device
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Nov 2023
Decision
112d
Days
Class 2
Risk

K232076 is an FDA 510(k) clearance for the Fibercure. Classified as Laser Activator For Polymerization (product code QNF), Class II - Special Controls.

Submitted by Lumendo AG (Renens, CH). The FDA issued a Cleared decision on November 2, 2023 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K232076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2023
Decision Date November 02, 2023
Days to Decision 112 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
15d faster than avg
Panel avg: 127d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QNF Laser Activator For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
Definition Intended To Polymerize Dental Restorative Resins
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.