Cleared Traditional

K002195 - FORAMATRON V, MODEL D680 (FDA 510(k) Clearance)

K002195 · Parkell, Inc. · Dental device
Aug 2000
Decision
41d
Days
—
Risk

K002195 is an FDA 510(k) clearance for the FORAMATRON V, MODEL D680. This device is classified as a Locator, Root Apex.

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on August 30, 2000, 41 days after receiving the submission on July 20, 2000.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K002195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2000
Decision Date August 30, 2000
Days to Decision 41 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code LQY — Locator, Root Apex
Device Class —