Cleared Traditional

K882145 - PHOTO-CURING LIGHT

K882145 is an FDA 510(k) clearance for PHOTO-CURING LIGHT, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K882145 · Dentsply Intl. · Dental device
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Sep 1988
Decision
106d
Days
Class 2
Risk

K882145 is an FDA 510(k) clearance for the PHOTO-CURING LIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on September 6, 1988 after a review of 106 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K882145

510(k) Number K882145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1988
Decision Date September 06, 1988
Days to Decision 106 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
21d faster than avg
Panel avg: 127d · This submission: 106d
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 161
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K882145.
HELIOLUX VISIBLE CURING LIGHT
K901908 · Ivoclar North America, Inc. · Jul 1990
TULUX-FILTER
K892517 · Espe GmbH (Us) · Aug 1989
KULZER TRANSLUX EC
K892456 · Kulzer, Inc. · Jun 1989
ORTHOLUX VISIBLE LIGHT CURING UNIT
K880392 · Unitek Corp. · Apr 1988
OP II VISIBLE LIGHT CURING SYSTEM
K854696 · Almore Intl., Inc. · Mar 1986
COE-LITE POLYMERIZATION UNIT
K844325 · Coe Laboratories, Inc. · Dec 1984