Cleared Traditional

K950857 - FORAMATRON IV (FDA 510(k) Clearance)

K950857 · Parkell, Inc. · Dental device
Apr 1995
Decision
52d
Days
—
Risk

K950857 is an FDA 510(k) clearance for the FORAMATRON IV. This device is classified as a Locator, Root Apex.

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on April 20, 1995, 52 days after receiving the submission on February 27, 1995.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K950857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1995
Decision Date April 20, 1995
Days to Decision 52 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code LQY — Locator, Root Apex
Device Class —