Cleared Traditional

K111474 - BINGO PRO (FDA 510(k) Clearance)

K111474 · Forum Engineering Technologies (96) , Ltd. · Dental device
Nov 2011
Decision
159d
Days
-
Risk

K111474 is an FDA 510(k) clearance for the BINGO PRO. This device is classified as a Locator, Root Apex.

Submitted by Forum Engineering Technologies (96) , Ltd. (Rishon Lezion, IL). The FDA issued a Cleared decision on November 2, 2011, 159 days after receiving the submission on May 27, 2011.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K111474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2011
Decision Date November 02, 2011
Days to Decision 159 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LQY - Locator, Root Apex
Device Class -