Cleared Traditional

K921979 - ROOT ZX

K921979 · J. Morita USA, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
394d
Days
-
Risk

K921979 is an FDA 510(k) clearance for the ROOT ZX. Classified as Locator, Root Apex (product code LQY).

Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on May 27, 1993 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K921979

510(k) Number K921979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1992
Decision Date May 27, 1993
Days to Decision 394 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
266d slower than avg
Panel avg: 128d · This submission: 394d
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 45
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K921979.
ROOT CANAL LENGTH MEASURING DEVICE
K953867 · J. Morita USA, Inc. · Dec 1995
FORAMATRON IV
K950857 · Parkell, Inc. · Apr 1995
PULPDENT CANAL FINDER
K945811 · Pulpdent Corp. · Jan 1995
OSADA ENDEX
K904742 · Osada Electric Co., Ltd. · Dec 1990
COATED APEX PROBE
K890735 · Analytic Technology · Apr 1989
ENDOCATER
K863393 · The Hygenic Corp. · Jun 1987
K921979 · ROOT ZX
Download PDF FDA Summary J. Morita USA, Inc.