Cleared Traditional

K925567 - E 4000 DENTAL OPERATING CHAIR

K925567 is an FDA 510(k) clearance for E 4000 DENTAL OPERATING CHAIR, manufactured by Dentalez Group. The device is a Class 1 Dental device with product code KLC cleared through the Traditional 510(k) pathway after a 492-day FDA review.

K925567 · Dentalez Group · Dental device
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Mar 1994
Decision
492d
Days
Class 1
Risk

K925567 is an FDA 510(k) clearance for the E 4000 DENTAL OPERATING CHAIR. Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by Dentalez Group (Lancaster, US). The FDA issued a Cleared decision on March 10, 1994 after a review of 492 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6250 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Dentalez Group devices

FDA 510(k) Submission Details - K925567

510(k) Number K925567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1992
Decision Date March 10, 1994
Days to Decision 492 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
365d slower than avg
Panel avg: 127d · This submission: 492d
Pathway characteristics
Predicate-based equivalence.

KLC Device Classification - Class 1, General Controls

Product Code KLC Chair, Dental, With Operative Unit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6250
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KLC Chair, Dental, With Operative Unit

All 28
Devices cleared under the same product code (KLC) and FDA review panel - the closest regulatory comparables to K925567.
OPTIMA PLUS E DENTAL CHAIR
K971063 · King Dental Corp. · Jun 1997
PROSTYLE COMPACT
K963209 · Planmeca Oy · Oct 1996
KAVO SYSTEMATICA 1060
K940950 · Kavo America · Dec 1994
A-DEC 1040 CHAIR
K925119 · A-Dec, Inc. · Jan 1994
A-DEC 2170 DUO UNIT CUSP
K925314 · A-Dec, Inc. · Dec 1993
A-DEC 2171 DUO UNIT
K925315 · A-Dec, Inc. · Dec 1993