Cleared Traditional

K913980 - HELIOLUX

K913980 is an FDA 510(k) clearance for HELIOLUX, manufactured by Ivoclar North America, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K913980

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.

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 158
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K913980.
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ORTHOLUX XT
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3M CURING LIGHT XL 3000
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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