Cleared Traditional

K121206 - DETECT

K121206 · Forum Engineering Technologies, Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
265d
Days
-
Risk

K121206 is an FDA 510(k) clearance for the DETECT. Classified as Locator, Root Apex (product code LQY).

Submitted by Forum Engineering Technologies, Ltd. (Rishon Lezion, IL). The FDA issued a Cleared decision on January 10, 2013 after a review of 265 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.

FDA 510(k) Submission Details - K121206

510(k) Number K121206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2012
Decision Date January 10, 2013
Days to Decision 265 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
137d slower than avg
Panel avg: 128d · This submission: 265d
Pathway characteristics
Predicate-based equivalence.

LQY Device Classification - Class 0,

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 42
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K121206 · DETECT
Download PDF FDA Summary Forum Engineering Tec…