Cleared Traditional

HELIOLUX (K913980) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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
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 36
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K913980.
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K930086 · 3M Company · Apr 1993
3M CURING LIGHT XL 3000
K924812 · 3M Company · Nov 1992
PHOTO-CURING LIGHT
K882145 · Dentsply Intl. · Sep 1988
PRISMA III
K832320 · Dentsply Intl. · Aug 1983
CAULK PRISMA-LITE
K801588 · Dentsply Intl. · Sep 1980