Cleared Traditional

K002581 - DURAGARD SODIUM FLUORIDE VARNISH

K002581 is an FDA 510(k) clearance for DURAGARD SODIUM FLUORIDE VARNISH, manufactured by Sultan Dental Products, Ltd.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K002581 · Sultan Dental Products, Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
63d
Days
Class 2
Risk

K002581 is an FDA 510(k) clearance for the DURAGARD SODIUM FLUORIDE VARNISH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Sultan Dental Products, Ltd. (Englewood, US). The FDA issued a Cleared decision on October 20, 2000 after a review of 63 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.

FDA 510(k) Submission Details - K002581

510(k) Number K002581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2000
Decision Date October 20, 2000
Days to Decision 63 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
65d faster than avg
Panel avg: 128d · This submission: 63d
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 138
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K002581.
QUELL DESENSITIZER
K010957 · Jeneric/Pentron, Inc. · Jun 2001
CAVITY VARNISH
K010255 · Rite-Dent Manufacturing Corp. · Apr 2001
PROCLUDE-SENSITIVE
K003482 · Ortek Therapeutics, Inc. · Feb 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
K002581 · DURAGARD SODIUM FLUORIDE VARNISH
Download PDF FDA Summary Sultan Dental Product…