Cleared Traditional

K843363 - RESTODENT VL

K843363 is an FDA 510(k) clearance for RESTODENT VL, manufactured by Lee Pharmaceuticals. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K843363 · Lee Pharmaceuticals · Dental device
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Oct 1984
Decision
58d
Days
Class 2
Risk

K843363 is an FDA 510(k) clearance for the RESTODENT VL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Lee Pharmaceuticals (South El Monte, US). The FDA issued a Cleared decision on October 25, 1984 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lee Pharmaceuticals devices

FDA 510(k) Submission Details - K843363

510(k) Number K843363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1984
Decision Date October 25, 1984
Days to Decision 58 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
69d faster than avg
Panel avg: 127d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 800
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K843363.
PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST
K850824 · Kuraray Co. · Apr 1985
KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI
K844662 · Kerr Corporation (Danbury) · Mar 1985
OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE
K844326 · Coe Laboratories, Inc. · Dec 1984
KERR GELLED PHOSPHORIC ACID ETCHANT
K843026 · Kerr Corporation (Danbury) · Sep 1984
EVER-BOND V GLASS LONOMER RESTORATIVE
K843072 · Kerr Corporation (Danbury) · Sep 1984
BISFIL-I LIGHT CURABLE POSTERIOR COMPO
K842087 · Bisco, Inc. · Jul 1984