Cleared Traditional

K003482 - PROCLUDE-SENSITIVE

K003482 is an FDA 510(k) clearance for PROCLUDE-SENSITIVE, manufactured by Ortek Therapeutics, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K003482 · Ortek Therapeutics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
84d
Days
Class 2
Risk

K003482 is an FDA 510(k) clearance for the PROCLUDE-SENSITIVE. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Ortek Therapeutics, Inc. (New York, US). The FDA issued a Cleared decision on February 1, 2001 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - 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 - K003482

510(k) Number K003482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2000
Decision Date February 01, 2001
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBH Device Classification - Class 2, Special Controls

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
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 - LBH Varnish, Cavity

All 83
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K003482.
SEAL & PROTECT PROTECTIVE SEALANT
K021805 · Dentsply Intl. · Aug 2002
PULPDENT CAVITY PREPARATION IV
K013411 · Pulpdent Corp. · Dec 2001
QUELL DESENSITIZER
K010957 · Jeneric/Pentron, Inc. · Jun 2001
PULPDENT CAVITY PREPARATION III
K994180 · Pulpdent Corp. · Mar 2000
PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE
K994181 · Pulpdent Corp. · Feb 2000
PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE
K994182 · Pulpdent Corp. · Feb 2000