Cleared Traditional

K944416 - LIFE

K944416 is the FDA 510(k) clearance for LIFE by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code EJK) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K944416 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
78d
Days
Class 2
Risk

K944416 is an FDA 510(k) clearance for the LIFE. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Glendora, US). The FDA issued a Cleared decision on November 29, 1994 after a review of 78 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 K944416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1994
Decision Date November 29, 1994
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
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 K944416.
ULTRA-BLEND
K953524 · Ultradent Products, Inc. · Aug 1995
LIMELIGHT
K953079 · Pulpdent Corp. · Aug 1995
PULPDENT CALCIUM HYDROXIDE PREPARATIONS
K944945 · Pulpdent Corp. · Nov 1994
CALCIUM HYDROXIDE PASTE
K943372 · Ultradent Products, Inc. · Sep 1994
NEEDLETUBE SYRINGE CARTRTIDGE
K933507 · Centrix, Inc. · Jan 1994
STERIBASE (ACCUBASE)
K933999 · Centrix, Inc. · Jan 1994