Cleared Traditional

K930086 - ORTHOLUX XT

K930086 is an FDA 510(k) clearance for ORTHOLUX XT, manufactured by 3M Company. 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.

K930086 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
106d
Days
Class 2
Risk

K930086 is an FDA 510(k) clearance for the ORTHOLUX XT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by 3M Company (Monrovia, US). The FDA issued a Cleared decision on April 23, 1993 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.

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FDA 510(k) Submission Details - K930086

510(k) Number K930086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1993
Decision Date April 23, 1993
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
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 141
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K930086.
COLTOLUX LIGHT METER
K950106 · Coltene/Whaledent, Inc. · May 1995
SPECTRUM CURING LIGHT POLYMERIZATION UNIT
K951425 · Dentsply Intl. · May 1995
3M CURING LIGHT XL1500
K934746 · 3M Company · Jan 1994
3M CURING LIGHT XL 3000
K924812 · 3M Company · Nov 1992
HELIOLUX
K913980 · Ivoclar North America, Inc. · Dec 1991
SPECTRAMAT
K910068 · Ivoclar North America, Inc. · Mar 1991