Cleared Traditional

K984247 - ELIPAR TRILIGHT

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

K984247 · Espe Dental AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K984247

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.

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 161
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K984247.
Q-LITE 75 LIGHT CURE UNIT
K991865 · Rolence Enterprise Co. , Ltd. · Jul 1999
CUTE-LITE I LIGHT CURE UNIT
K991863 · Rolence Enterprise Co. , Ltd. · Jul 1999
LYSTA LC CURING LIGHT, MODEL LC 2500C/BA
K991138 · Lysta A/S · Apr 1999
AIRDENT RADIANCE CURING LIGHT
K982615 · Air Techniques, Inc. · Aug 1998
APOLLO 9500
K974369 · Ion Laser Technology · Jan 1998
3M AURORA SYSTEM
K972355 · 3M Company · Aug 1997