Cleared Traditional

K913980 - HELIOLUX

K913980 is the FDA 510(k) clearance for HELIOLUX by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EBZ) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K913980 · Ivoclar North America, Inc. · Dental device
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Dec 1991
Decision
101d
Days
Class 2
Risk

K913980 is an FDA 510(k) clearance for the HELIOLUX. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on December 16, 1991 after a review of 101 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 Ivoclar North America, Inc. devices

Submission Details

510(k) Number K913980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1991
Decision Date December 16, 1991
Days to Decision 101 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 127d · This submission: 101d
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 77
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K913980.
3M CURING LIGHT XL1500
K934746 · 3M Company · Jan 1994
ORTHOLUX XT
K930086 · 3M Company · Apr 1993
3M CURING LIGHT XL 3000
K924812 · 3M Company · Nov 1992
SPECTRAMAT
K910068 · Ivoclar North America, Inc. · Mar 1991
HELIOLUX VISIBLE CURING LIGHT
K901908 · Ivoclar North America, Inc. · Jul 1990
TULUX-FILTER
K892517 · Espe GmbH (Us) · Aug 1989