Cleared Traditional

ELAN-2 (K983091) - FDA 510(k) Clearance

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

K983091 · Kerr Dental Materials Center · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
55d
Days
Class 2
Risk

K983091 is an FDA 510(k) clearance for the ELAN-2. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kerr Dental Materials Center (Orange, US). The FDA issued a Cleared decision on October 28, 1998 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Kerr Dental Materials Center devices

Submission Details

510(k) Number K983091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1998
Decision Date October 28, 1998
Days to Decision 55 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 127d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 195
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K983091.
3M ESPE HAUR
K010781 · 3M Company · Apr 2001
3M LVR SYSTEM
K991961 · 3M Company · Aug 1999
R-30 AESTHETIC RESTORATIVE
K984387 · Dentsply Intl. · Jan 1999
SPECTRUM 800 CURING UNIT
K982318 · Dentsply Intl. · Sep 1998
DYTRACT FLOW RESTORATIVE
K982395 · Dentsply Intl. · Aug 1998
3M DENT II SYSTEM
K981647 · 3M Company · Aug 1998