Cleared Traditional

K924378 - RESTOBOND 4

K924378 is an FDA 510(k) clearance for RESTOBOND 4, 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 212-day FDA review.

K924378 · Lee Pharmaceuticals · Dental device
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Mar 1993
Decision
212d
Days
Class 2
Risk

K924378 is an FDA 510(k) clearance for the RESTOBOND 4. 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 March 31, 1993 after a review of 212 days - an extended review cycle.

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 - K924378

510(k) Number K924378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1992
Decision Date March 31, 1993
Days to Decision 212 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 127d · This submission: 212d
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 K924378.
DENTHESIVE II
K931838 · Heraeus Kulzer, Inc. · Jul 1993
NEW DENTIN PRIMER
K930504 · Dentsply Intl. · May 1993
PULPDENT UNFILLED DUAL CURE BONDING RESIN
K930989 · Pulpdent Corp. · Apr 1993
CLEARFIL PORCELAIN BOND ACTIVATOR
K925404 · Kuraray Co. · Jan 1993
POLIBOND
K924181 · Voco GmbH · Oct 1992
OPTIBOND
K923546 · Kerr Corporation (Danbury) · Sep 1992