Cleared Traditional

K894315 - RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT

K894315 is the FDA 510(k) clearance for RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT by Lee Pharmaceuticals. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K894315 · Lee Pharmaceuticals · Dental device
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Oct 1989
Decision
109d
Days
Class 2
Risk

K894315 is an FDA 510(k) clearance for the RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Lee Pharmaceuticals (South El Monte, US). The FDA issued a Cleared decision on October 31, 1989 after a review of 109 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 K894315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1989
Decision Date October 31, 1989
Days to Decision 109 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
18d faster than avg
Panel avg: 127d · This submission: 109d
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 290
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K894315.
9.6% HYDROFLUORIC ACID GEL
K896655 · Pulpdent Corp. · Feb 1990
SILANE
K896659 · Pulpdent Corp. · Feb 1990
MODIFIED GLUMA BONDING SYSTEM
K896382 · Heraeus Kulzer, Inc. · Feb 1990
DENTIN PRIMER
K891455 · Dentsply Intl. · May 1989
KETAC-GLAZE
K884752 · Espe GmbH (Us) · Jan 1989
XR PRIMER
K880684 · Kerr Corporation (Danbury) · May 1988