Cleared Traditional

OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS (K994435) - FDA 510(k) Clearance

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

K994435 · Jeneric/Pentron, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Feb 2000
Decision
42d
Days
Class 2
Risk

K994435 is an FDA 510(k) clearance for the OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on February 10, 2000 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 Jeneric/Pentron, Inc. devices

Submission Details

510(k) Number K994435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1999
Decision Date February 10, 2000
Days to Decision 42 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 127d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 185
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K994435.
CERCON CERAM S PORCELAIN
K022796 · Dentsply Intl. · Sep 2002
ERIS LAYERING MATERIALS
K012174 · Ivoclar North America, Inc. · Aug 2001
PROCAD ADD-ON
K003373 · Ivoclar North America, Inc. · Nov 2000
3M TR SYSTEM
K992489 · 3M Company · Jan 2000
IPS D.SIGN PORCELAIN
K990817 · Ivoclar North America, Inc. · Apr 1999
IPS EMPRESS 2
K982616 · Ivoclar North America, Inc. · Sep 1998