Cleared Traditional

K002989 - PROCLUDE

K002989 is an FDA 510(k) clearance for PROCLUDE, manufactured by Ortek Therapeutics, Inc.. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K002989 · Ortek Therapeutics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
80d
Days
Class 1
Risk

K002989 is an FDA 510(k) clearance for the PROCLUDE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Ortek Therapeutics, Inc. (New York, US). The FDA issued a Cleared decision on December 14, 2000 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6030 - 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 Ortek Therapeutics, Inc. devices

FDA 510(k) Submission Details - K002989

510(k) Number K002989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2000
Decision Date December 14, 2000
Days to Decision 80 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
47d faster than avg
Panel avg: 127d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

EJR Device Classification - Class 1, General Controls

Product Code EJR Agent, Polishing, Abrasive, Oral Cavity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6030
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EJR Agent, Polishing, Abrasive, Oral Cavity

All 31
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K002989.
GC MI PASTE PLUS
K070854 · GC America, Inc. · Apr 2007
ENAMEL PRO
K062166 · Premier Dental Products Co. · Nov 2006
MI PASTE
K042200 · GC America, Inc. · Oct 2004
NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
K000169 · Dentsply Intl. · Mar 2000
NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN
K983966 · Dentsply Intl. · Jan 1999
SATIN PROPHYLAXIS PASTE
K912945 · Dentsply Intl. · Sep 1991