Cleared Traditional

K924378 - RESTOBOND 4

K924378 is the FDA 510(k) clearance for RESTOBOND 4 by Lee Pharmaceuticals. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K924378 · Lee Pharmaceuticals · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 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
POLIBOND
K924181 · Voco GmbH · Oct 1992
OPTIBOND
K923546 · Kerr Corporation (Danbury) · Sep 1992
BISCO UNIVERSAL BOND-3
K923842 · Bisco, Inc. · Sep 1992