Cleared Traditional

K022147 - DENTA PORT

K022147 · J. Morita USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
171d
Days
-
Risk

K022147 is an FDA 510(k) clearance for the DENTA PORT. Classified as Locator, Root Apex (product code LQY).

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on December 20, 2002 after a review of 171 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 J. Morita USA, Inc. devices

FDA 510(k) Submission Details - K022147

510(k) Number K022147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2002
Decision Date December 20, 2002
Days to Decision 171 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 127d · This submission: 171d
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 29
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K022147.
BINGO PRO
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MULTIPLE (APEX LOCATOR), MODEL RCM-7
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K030895 · Aseptico, Inc. · Dec 2003
FORAMATRON V, MODEL D680
K002195 · Parkell, Inc. · Aug 2000
APEX LOCATOR BINGO-1020
K992233 · Dent Corp. Research & Development · Nov 1999
ROOT APEX LOCATOR
K972407 · Toei Electric Co., Ltd. · Sep 1997