Cleared Traditional

K854696 - OP II VISIBLE LIGHT CURING SYSTEM

K854696 is an FDA 510(k) clearance for OP II VISIBLE LIGHT CURING SYSTEM, manufactured by Almore Intl., Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K854696

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
Combination Product No
PCCP Authorized No
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.

EBZ Device Classification - Class 2, Special Controls

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 153
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K854696.
KULZER TRANSLUX EC
K892456 · Kulzer, Inc. · Jun 1989
PHOTO-CURING LIGHT
K882145 · Dentsply Intl. · Sep 1988
ORTHOLUX VISIBLE LIGHT CURING UNIT
K880392 · Unitek Corp. · Apr 1988
COE-LITE POLYMERIZATION UNIT
K844325 · Coe Laboratories, Inc. · Dec 1984
TRANSLUX CL
K843823 · Kulzer, Inc. · Dec 1984
PRISMA III
K832320 · Dentsply Intl. · Aug 1983