Cleared Traditional

OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT (K874162) - FDA 510(k) Clearance

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

K874162 · Pentron Corp. · Dental device
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Jan 1988
Decision
91d
Days
Class 2
Risk

K874162 is an FDA 510(k) clearance for the OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Pentron Corp. (Wallingford, US). The FDA issued a Cleared decision on January 12, 1988 after a review of 91 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 Pentron Corp. devices

Submission Details

510(k) Number K874162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date January 12, 1988
Days to Decision 91 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 195
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K874162.
3M BRAND RESTORATIVE Z100
K920425 · 3M Company · Mar 1992
STOMADENT TM
K905476 · Dentsply Intl. · Feb 1991
DENTAL CORE MATERIAL
K896564 · Dentsply Intl. · Feb 1990
SILUX PLUS LIGHT CURED RESTORATIVE MATERIAL
K872444 · 3M Company · Sep 1987
DENTIN ADHESIVE
K872907 · Dentsply Intl. · Aug 1987
SCOTCHBOND 2 ADHESIVE W/SCOTCHPREP DENTIN PRIMER
K872279 · 3M Company · Jul 1987