Cleared Traditional

K894060 - ESSE QUATTRO/ESSE UNO

K894060 is the FDA 510(k) clearance for ESSE QUATTRO/ESSE UNO by Eurodent, Inc.. It is a Class 1 Dental device (product code KLC) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K894060 · Eurodent, Inc. · Dental device
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Sep 1989
Decision
92d
Days
Class 1
Risk

K894060 is an FDA 510(k) clearance for the ESSE QUATTRO/ESSE UNO. Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by Eurodent, Inc. (Canada J4b 5z5, CA). The FDA issued a Cleared decision on September 7, 1989 after a review of 92 days - within the typical 510(k) review window.

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: 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 Eurodent, Inc. devices

Submission Details

510(k) Number K894060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1989
Decision Date September 07, 1989
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 127d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 23
Devices cleared under the same product code (KLC) and FDA review panel - the closest regulatory comparables to K894060.
A-DEC KNEEBREAK 1030 CHAIR
K913059 · A-Dec, Inc. · Oct 1991
A-DEC DECADE 1015 CHAIR
K903450 · A-Dec, Inc. · Oct 1990
A-DEC DECADE 1010 CHAIR
K903454 · A-Dec, Inc. · Oct 1990
A-DEC PRIORITY 1005 CHAIR
K893045 · A-Dec, Inc. · Jul 1989
HERPES-IHA KIT
K822095 · Hillcrest Biologicals · Apr 1983
RITTER MODEL H COMPANION STOOL
K800276 · Sybron Corp. · Mar 1980