Cleared Traditional

K992822 - SEAL & PROTECT PROTECTIVE SEALANT FOR E...

K992822 is the FDA 510(k) clearance for SEAL & PROTECT PROTECTIVE SEALANT FOR E... by Dentsply Intl.. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K992822 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
86d
Days
Class 2
Risk

K992822 is an FDA 510(k) clearance for the SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on November 17, 1999 after a review of 86 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 Dentsply Intl. devices

Submission Details

510(k) Number K992822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1999
Decision Date November 17, 1999
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 78
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K992822.
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
D/SENSE II (GREEN-OR) DENTIN DESENSITIZER
K992629 · Centrix, Inc. · Oct 1999
SCI-PHARM DFV VARNISH
K982915 · Scientific Pharmaceuticals, Inc. · Feb 1999
SCI-PHARM DESENSITIZING VARNISH
K983305 · Scientific Pharmaceuticals, Inc. · Dec 1998