Cleared Traditional

K012717 - LIFE 2

K012717 is the FDA 510(k) clearance for LIFE 2 by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code EJK) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K012717 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
71d
Days
Class 2
Risk

K012717 is an FDA 510(k) clearance for the LIFE 2. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on October 25, 2001 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3250 - 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

Submission Details

510(k) Number K012717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2001
Decision Date October 25, 2001
Days to Decision 71 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
56d faster than avg
Panel avg: 127d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJK Liner, Cavity, Calcium Hydroxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3250
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 - EJK Liner, Cavity, Calcium Hydroxide

All 40
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K012717.
APEXCAL
K060365 · Ivoclar Vivadent, Inc. · Apr 2006
BISBLOCK
K033521 · Bisco, Inc. · Jan 2004
D/SENSE 1-STEP
K021146 · Centrix, Inc. · Jul 2002
CALCIJECT
K001050 · Centrix, Inc. · Jul 2000
ULTRA-BLEND PLUS
K970113 · Ultradent Products, Inc. · Apr 1997
ULTRACAL XS
K970114 · Ultradent Products, Inc. · Mar 1997