Cleared Traditional

RESTODENT DENTIN BONDING AGENT (K840726) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K840726 · Lee Pharmaceuticals · Dental device
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Jun 1984
Decision
127d
Days
Class 2
Risk

K840726 is an FDA 510(k) clearance for the RESTODENT DENTIN BONDING AGENT. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Lee Pharmaceuticals (Mchenry, US). The FDA issued a Cleared decision on June 27, 1984 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 Lee Pharmaceuticals devices

Submission Details

510(k) Number K840726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1984
Decision Date June 27, 1984
Days to Decision 127 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 127d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 83
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K840726.
ETCH AND BOND
K852660 · Dentsply Intl. · Jul 1985
OPAQUER/BONDING AGENT
K851056 · Dentsply Intl. · Apr 1985
JOHNSON & JOHNSON FLAVORED ETCHING GEL
K842078 · Johnson & Johnson Professionals, Inc. · Jul 1984
ETCHING GEL
K833718 · Johnson & Johnson Professionals, Inc. · Dec 1983
DENTIN BONDING AGENT
K833473 · Johnson & Johnson Professionals, Inc. · Dec 1983
MICRODAPT DENTAL RESTORATIVE BONDING
K830387 · Johnson & Johnson Professionals, Inc. · Mar 1983