Cleared Traditional

Apex Locator

K231990 · Cefla S.C. · Dental
Feb 2024
Decision
223d
Days
—
Risk

About This 510(k) Submission

K231990 is an FDA 510(k) clearance for the Apex Locator, a Locator, Root Apex, submitted by Cefla S.C. (Imola, IT). The FDA issued a Cleared decision on February 13, 2024, 223 days after receiving the submission on July 5, 2023. This device falls under the Dental review panel.

Submission Details

510(k) Number K231990 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LQY — Locator, Root Apex
Device Class —

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