Cleared Traditional

K002387 - COMFORT CONTROL SYRINGE SYSTEM

K002387 is the FDA 510(k) clearance for COMFORT CONTROL SYRINGE SYSTEM by Dentsply Intl.. It is a Class 2 Dental device (product code EJI) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K002387 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
55d
Days
Class 2
Risk

K002387 is an FDA 510(k) clearance for the COMFORT CONTROL SYRINGE SYSTEM. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on September 28, 2000 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6770 - 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 Dentsply Intl. devices

Submission Details

510(k) Number K002387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2000
Decision Date September 28, 2000
Days to Decision 55 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
72d faster than avg
Panel avg: 127d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJI Syringe, Cartridge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6770
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 - EJI Syringe, Cartridge

Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K002387.
Miltex N-Tralig Intraligamentary Syringe
K142414 · Integra LifeSciences Corporation · Oct 2014
IMPULSE SEALER PRODUCT LINE
K943370 · Ultradent Products, Inc. · Oct 1994
CITOJECT CARTRIDGE SYRINGE
K842006 · Miles Laboratories, Inc. · Jul 1984
MULTI-PURPOSE DENTAL SYRINGE
K811831 · Centrix, Inc. · Sep 1981
MONOJECT PLASTIC DENTAL INJ. SYRINGE
K792541 · Sherwood Medical Co. · Feb 1980