Cleared Traditional

K984247 - ELIPAR TRILIGHT

K984247 is the FDA 510(k) clearance for ELIPAR TRILIGHT by Espe Dental AG. It is a Class 2 Dental device (product code EBZ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K984247 · Espe Dental AG · Dental device
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Feb 1999
Decision
90d
Days
Class 2
Risk

K984247 is an FDA 510(k) clearance for the ELIPAR TRILIGHT. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Espe Dental AG (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on February 25, 1999 after a review of 90 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 Espe Dental AG devices

Submission Details

510(k) Number K984247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1998
Decision Date February 25, 1999
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
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 79
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K984247.
AVANTE CURELIGHT
K003683 · Jeneric/Pentron, Inc. · Jan 2001
JETLITE 4000
K000078 · J. Morita USA, Inc. · May 2000
VIP- VARIABLE INTENSITY POLYMERIZER
K000426 · Bisco, Inc. · Apr 2000
3M AURORA SYSTEM
K972355 · 3M Company · Aug 1997
JETLITE
K963110 · J. Morita USA, Inc. · Oct 1996
SPECTRUM CURING LIGHT POLYMERIZATION UNIT
K951425 · Dentsply Intl. · May 1995