Cleared Traditional

K231990 - Apex Locator (FDA 510(k) Clearance)

K231990 · Cefla S.C. · Dental device
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Optimized for regulatory review, auditing and printing
Feb 2024
Decision
223d
Days
-
Risk

K231990 is an FDA 510(k) clearance for the Apex Locator. Classified as Locator, Root Apex (product code LQY).

Submitted by Cefla S.C. (Imola, IT). The FDA issued a Cleared decision on February 13, 2024 after a review of 223 days - an extended review cycle.

This device falls under the Dental FDA review panel. 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.

View all Cefla S.C. devices

Submission Details

510(k) Number K231990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2023
Decision Date February 13, 2024
Days to Decision 223 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
96d slower than avg
Panel avg: 127d · This submission: 223d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -