Cleared Traditional

K990779 - HEMASEAL & CIDE

K990779 is an FDA 510(k) clearance for HEMASEAL & CIDE, manufactured by Advantage Dental Products, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K990779 · Advantage Dental Products, Inc. · Dental device
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Nov 1999
Decision
253d
Days
Class 2
Risk

K990779 is an FDA 510(k) clearance for the HEMASEAL & CIDE. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Advantage Dental Products, Inc. (Clarkson, US). The FDA issued a Cleared decision on November 17, 1999 after a review of 253 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Advantage Dental Products, Inc. devices

FDA 510(k) Submission Details - K990779

510(k) Number K990779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1999
Decision Date November 17, 1999
Days to Decision 253 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 127d · This submission: 253d
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 101
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K990779.
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
SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE
K992822 · Dentsply Intl. · Nov 1999
D/SENSE II (GREEN-OR) DENTIN DESENSITIZER
K992629 · Centrix, Inc. · Oct 1999
SCI-PHARM DFV VARNISH
K982915 · Scientific Pharmaceuticals, Inc. · Feb 1999