Cleared Traditional

K854696 - OP II VISIBLE LIGHT CURING SYSTEM

K854696 is the FDA 510(k) clearance for OP II VISIBLE LIGHT CURING SYSTEM by Almore Intl., Inc.. It is a Class 2 Dental device (product code EBZ) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K854696 · Almore Intl., Inc. · Dental device
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Mar 1986
Decision
125d
Days
Class 2
Risk

K854696 is an FDA 510(k) clearance for the OP II VISIBLE LIGHT CURING SYSTEM. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Almore Intl., Inc. (Portland, US). The FDA issued a Cleared decision on March 26, 1986 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - 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 Almore Intl., Inc. devices

Submission Details

510(k) Number K854696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1985
Decision Date March 26, 1986
Days to Decision 125 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 127d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBZ Activator, Ultraviolet, For Polymerization

All 74
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K854696.
HELIOLUX VISIBLE CURING LIGHT
K901908 · Ivoclar North America, Inc. · Jul 1990
TULUX-FILTER
K892517 · Espe GmbH (Us) · Aug 1989
PHOTO-CURING LIGHT
K882145 · Dentsply Intl. · Sep 1988
PRISMA III
K832320 · Dentsply Intl. · Aug 1983
CAULK PRISMA-LITE
K801588 · Dentsply Intl. · Sep 1980
FOTOFILL ACTIVATOR LIGHT
K772278 · Johnson & Johnson Professionals, Inc. · Jan 1978