Cleared Traditional

K021797 - L.E.DEMETRON

K021797 is an FDA 510(k) clearance for L.E.DEMETRON, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K021797 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
27d
Days
Class 2
Risk

K021797 is an FDA 510(k) clearance for the L.E.DEMETRON. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on June 27, 2002 after a review of 27 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 Sybron Dental Specialties, Inc. devices

FDA 510(k) Submission Details - K021797

510(k) Number K021797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2002
Decision Date June 27, 2002
Days to Decision 27 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
100d faster than avg
Panel avg: 127d · This submission: 27d
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 126
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K021797.
SLED CURING LIGHT SYSTEM
K031615 · Dentsply International · Jul 2003
RADII
K030568 · Southern Dental Industries, Inc. · Apr 2003
PALMLIGHT
K020057 · CAO Group, Inc. · Aug 2002
OPTILUX CURING LIGHTS
K020267 · Sybron Dental Specialties, Inc. · Mar 2002
OPTILUX 501
K020091 · Kerr Corporation (Danbury) · Mar 2002
KAVO POLYLUX II
K013500 · Kavo America · Jan 2002