Cleared Traditional

RESTOBOND 4 (K924378) - FDA 510(k) Clearance

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

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

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
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 83
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K924378.
FLUORIDE-PSA PRIME/ADHESIVE
K941572 · Dentsply Intl. · Jun 1994
NEW DENTINE ADHESIVE
K931812 · Dentsply Intl. · Jul 1993
NEW DENTIN PRIMER
K930504 · Dentsply Intl. · May 1993
SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM
K920424 · 3M Company · Mar 1992
PRISMA UNIVERSAL BOND(R) 3
K915830 · Dentsply Intl. · Mar 1992
DENTIN PRIMER
K891455 · Dentsply Intl. · May 1989