Cleared Traditional

K862695 - FLUOR-ETCH GEL ETCHANT

K862695 is an FDA 510(k) clearance for FLUOR-ETCH GEL ETCHANT, manufactured by Teledyne, Inc.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K862695 · Teledyne, Inc. · Dental device
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Jul 1986
Decision
16d
Days
Class 2
Risk

K862695 is an FDA 510(k) clearance for the FLUOR-ETCH GEL ETCHANT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Teledyne, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on July 31, 1986 after a review of 16 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 Teledyne, Inc. devices

FDA 510(k) Submission Details - K862695

510(k) Number K862695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1986
Decision Date July 31, 1986
Days to Decision 16 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 127d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

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 107
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K862695.
MODIFIED VISIO-SEAL
K873069 · Espe GmbH (Us) · Sep 1987
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
PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT
K854882 · Lee Pharmaceuticals · Jan 1986
PIT AND FISSURE SEAANTS
K844308 · Dentsply Intl. · Jan 1985