Cleared Traditional

K953898 - ACL-5500 PRECISION CURING UNIT (PCU)

K953898 is an FDA 510(k) clearance for ACL-5500 PRECISION CURING UNIT (PCU), manufactured by Ion Laser Technology. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K953898 · Ion Laser Technology · Dental device
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Feb 1996
Decision
181d
Days
Class 2
Risk

K953898 is an FDA 510(k) clearance for the ACL-5500 PRECISION CURING UNIT (PCU). Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Ion Laser Technology (Salt Lake City, US). The FDA issued a Cleared decision on February 15, 1996 after a review of 181 days - an extended review cycle.

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 Ion Laser Technology devices

FDA 510(k) Submission Details - K953898

510(k) Number K953898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1995
Decision Date February 15, 1996
Days to Decision 181 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
54d slower than avg
Panel avg: 127d · This submission: 181d
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 104
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K953898.
ILT ARGON HP
K964524 · Ion Laser Technology · Mar 1997
JETLITE
K963110 · J. Morita USA, Inc. · Oct 1996
ACTA
K961735 · Satelec · Jul 1996
COLTOLUX 3, COLTOLUX 4
K945698 · Coltene/Whaledent, Inc. · May 1995
COLTOLUX LIGHT METER
K950106 · Coltene/Whaledent, Inc. · May 1995
SPECTRUM CURING LIGHT POLYMERIZATION UNIT
K951425 · Dentsply Intl. · May 1995