Cleared Traditional

COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE (K912994) - FDA 510(k) Clearance

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

K912994 · Wilde-USA, Inc. · Dental device
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Dec 1991
Decision
168d
Days
Class 2
Risk

K912994 is an FDA 510(k) clearance for the COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Wilde-USA, Inc. (Naperville, US). The FDA issued a Cleared decision on December 23, 1991 after a review of 168 days - an extended review 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: 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 Wilde-USA, Inc. devices

Submission Details

510(k) Number K912994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date December 23, 1991
Days to Decision 168 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
41d slower than avg
Panel avg: 127d · This submission: 168d
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 K912994.
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
PHOTO-CURING LIGHT
K882145 · Dentsply Intl. · Sep 1988
PRISMA III
K832320 · Dentsply Intl. · Aug 1983
CAULK PRISMA-LITE
K801588 · Dentsply Intl. · Sep 1980