Cleared Traditional

K854692 - MONARCH II BLEACHING INSTRUMENT

K854692 is an FDA 510(k) clearance for MONARCH II BLEACHING INSTRUMENT, manufactured by Almore Intl., Inc.. The device is a Class 1 Dental device with product code EEG cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K854692 · Almore Intl., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
172d
Days
Class 1
Risk

K854692 is an FDA 510(k) clearance for the MONARCH II BLEACHING INSTRUMENT. Classified as Heat Source For Bleaching Teeth (product code EEG), Class I - General Controls.

Submitted by Almore Intl., Inc. (Portland, US). The FDA issued a Cleared decision on May 12, 1986 after a review of 172 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6475 - 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.

FDA 510(k) Submission Details - K854692

510(k) Number K854692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1985
Decision Date May 12, 1986
Days to Decision 172 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
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: 128d · This submission: 172d
Pathway characteristics
Predicate-based equivalence.

EEG Device Classification - Class 1, General Controls

Product Code EEG Heat Source For Bleaching Teeth
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6475
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 - EEG Heat Source For Bleaching Teeth

All 11
Devices cleared under the same product code (EEG) and FDA review panel - the closest regulatory comparables to K854692.
UNION BROACH BLEACHING LIGHT
K895174 · Union Broach, Div. Moyco Industries, Inc. · Apr 1990
BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING
K884937 · Grass-Telefactor Product Group · Apr 1989
SCHEIN BLEACHING UNIT
K862385 · Henry Schein, Inc. · Oct 1986
HOT PROBE MODEL 6001
K832179 · Analytic Technology · Oct 1983
REYNOLDS BLEACHING PROCESS
K790378 · Reynolds Laboratories · Apr 1979
K854692 · MONARCH II BLEACHING INSTRUMENT
Download PDF Almore Intl., Inc.