Cleared Traditional

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

K111474 · Forum Engineering Technologies (96) , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
159d
Days
-
Risk

K111474 is an FDA 510(k) clearance for the BINGO PRO. Classified as Locator, Root Apex (product code LQY).

Submitted by Forum Engineering Technologies (96) , Ltd. (Rishon Lezion, IL). The FDA issued a Cleared decision on November 2, 2011 after a review of 159 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 Forum Engineering Technologies (96) , Ltd. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 127d · This submission: 159d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -