Cleared Traditional

KERR PORCELITE (K860346) - FDA 510(k) Clearance

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

K860346 · Kerr Corporation (Danbury) · Dental device

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Mar 1986

Decision

55d

Days

Class 2

Risk

K860346 is an FDA 510(k) clearance for the KERR PORCELITE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Kerr Corporation (Danbury) (Washington, US). The FDA issued a Cleared decision on March 25, 1986 after a review of 55 days - a notably fast clearance 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: 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 Kerr Corporation (Danbury) devices

Submission Details

510(k) Number	K860346 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 29, 1986
Decision Date	March 25, 1986
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

72d faster than avg

Panel avg: 127d · This submission: 55d

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 K860346.

DENTIN PRIMER

K891455 · Dentsply Intl. · May 1989

TEMPORARY DISCLOSING SOLUTION

K874074 · Dentsply Intl. · Dec 1987

MODIFIED SELF-CURE BONDING AGENT

K863522 · Dentsply Intl. · Sep 1986

ETCH AND BOND

K852660 · Dentsply Intl. · Jul 1985

OPAQUER/BONDING AGENT

K851056 · Dentsply Intl. · Apr 1985

JOHNSON & JOHNSON FLAVORED ETCHING GEL

K842078 · Johnson & Johnson Professionals, Inc. · Jul 1984

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K860346

Kerr Corporation (Danbury)

Washington, DC · US

KURZMAN, P.C

Regulatory profile

32 submissions 32 cleared

100% clearance rate · Active in Dental

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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