Cleared Traditional

K844662 - KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI

K844662 is an FDA 510(k) clearance for KERR HERCULITE DENTAL COMPOSITE RESTORA..., manufactured by Kerr Corporation (Danbury). The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K844662 · Kerr Corporation (Danbury) · Dental device
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Mar 1985
Decision
115d
Days
Class 2
Risk

K844662 is an FDA 510(k) clearance for the KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kerr Corporation (Danbury) (Washington, US). The FDA issued a Cleared decision on March 25, 1985 after a review of 115 days - within the typical 510(k) review window.

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: 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 Kerr Corporation (Danbury) devices

FDA 510(k) Submission Details - K844662

510(k) Number K844662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1984
Decision Date March 25, 1985
Days to Decision 115 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
12d faster than avg
Panel avg: 127d · This submission: 115d
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 798
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K844662.
KULZER DENTIN ADHESIVE
K850965 · Kulzer, Inc. · Apr 1985
TRIAD C & B MATERIAL
K850911 · Dentsply Intl. · Apr 1985
PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST
K850824 · Kuraray Co. · Apr 1985
OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE
K844326 · Coe Laboratories, Inc. · Dec 1984
RESTODENT VL
K843363 · Lee Pharmaceuticals · Oct 1984
KERR GELLED PHOSPHORIC ACID ETCHANT
K843026 · Kerr Corporation (Danbury) · Sep 1984