Cleared Traditional

K901908 - HELIOLUX VISIBLE CURING LIGHT

K901908 is the FDA 510(k) clearance for HELIOLUX VISIBLE CURING LIGHT by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EBZ) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K901908 · Ivoclar North America, Inc. · Dental device
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Jul 1990
Decision
78d
Days
Class 2
Risk

K901908 is an FDA 510(k) clearance for the HELIOLUX VISIBLE CURING LIGHT. 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 July 13, 1990 after a review of 78 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ivoclar North America, Inc. devices

Submission Details

510(k) Number K901908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1990
Decision Date July 13, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 127d · This submission: 78d
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 K901908.
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
TULUX-FILTER
K892517 · Espe GmbH (Us) · Aug 1989
KULZER TRANSLUX EC
K892456 · Kulzer, Inc. · Jun 1989
PHOTO-CURING LIGHT
K882145 · Dentsply Intl. · Sep 1988