Cleared Traditional

K894315 - RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT

K894315 is an FDA 510(k) clearance for RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT, manufactured by Lee Pharmaceuticals. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K894315

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.

KLE Device Classification - Class 2, Special Controls

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 381
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 BONDING SYSTEM
K894994 · Cosmedent, Inc. · Oct 1989
DENTIN PRIMER
K891455 · Dentsply Intl. · May 1989
TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING
K885010 · Coe Laboratories, Inc. · Feb 1989