Cleared Traditional

K930086 - ORTHOLUX XT

K930086 is the FDA 510(k) clearance for ORTHOLUX XT by 3M Company. It is a Class 2 Dental device (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.

View all 3M Company devices

Submission Details

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.

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 64
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K930086.
JETLITE
K963110 · J. Morita USA, Inc. · Oct 1996
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