Cleared Traditional

K854882 - PROTEC/VISIBLE LIGHT-CURED SEALANT/DENT...

K854882 is the FDA 510(k) clearance for PROTEC/VISIBLE LIGHT-CURED SEALANT/DENT... by Lee Pharmaceuticals. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K854882 · Lee Pharmaceuticals · Dental device
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Jan 1986
Decision
55d
Days
Class 2
Risk

K854882 is an FDA 510(k) clearance for the PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Lee Pharmaceuticals (South El Monte, US). The FDA issued a Cleared decision on January 30, 1986 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 Lee Pharmaceuticals devices

Submission Details

510(k) Number K854882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1985
Decision Date January 30, 1986
Days to Decision 55 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 127d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 77
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K854882.
ALPHA-DENT PIT AND FISSURE SEALANT
K870579 · Wallace A. Erickson & Co. · Mar 1987
PRISMA METAL OPAQUERS
K862660 · Dentsply Intl. · Jul 1986
SEALITE
K862284 · Sybron Corp. · Jun 1986
PIT AND FISSURE SEAANTS
K844308 · Dentsply Intl. · Jan 1985
CONCISE LIGHT CURED WHITE SEALANT
K844211 · 3M Company · Jan 1985
COMMAND ULTRASEAL PIT & FISSURE SEALANT
K843024 · Kerr Corporation (Danbury) · Sep 1984