Cleared Traditional

K992233 - APEX LOCATOR BINGO-1020

K992233 · Dent Corp. Research & Development · Dental device
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Nov 1999
Decision
158d
Days
-
Risk

K992233 is an FDA 510(k) clearance for the APEX LOCATOR BINGO-1020. Classified as Locator, Root Apex (product code LQY).

Submitted by Dent Corp. Research & Development (White Plains, US). The FDA issued a Cleared decision on November 30, 1999 after a review of 158 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 Dent Corp. Research & Development devices

FDA 510(k) Submission Details - K992233

510(k) Number K992233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1999
Decision Date November 30, 1999
Days to Decision 158 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 127d · This submission: 158d
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 24
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K992233.
ASEPTICO ENDOPEX V, MODEL AEU-40
K030895 · Aseptico, Inc. · Dec 2003
DENTA PORT
K022147 · J. Morita USA, Inc. · Dec 2002
FORAMATRON V, MODEL D680
K002195 · Parkell, Inc. · Aug 2000
ROOT APEX LOCATOR
K972407 · Toei Electric Co., Ltd. · Sep 1997
APEX FINDER MODELS 7005
K962803 · Sybron Dental Specialties, Inc. · Oct 1996
NEOSONO
K962853 · L.S. Scientific · Sep 1996