Cleared Traditional

CONQUEST CRYSTAL (K932154) - FDA 510(k) Clearance

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

K932154 · Jeneric/Pentron, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
134d
Days
Class 2
Risk

K932154 is an FDA 510(k) clearance for the CONQUEST CRYSTAL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on September 15, 1993 after a review of 134 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 Jeneric/Pentron, Inc. devices

Submission Details

510(k) Number K932154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1993
Decision Date September 15, 1993
Days to Decision 134 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 127d · This submission: 134d
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 292
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K932154.
CHARISMA SUPERLIGHT
K935736 · Heraeus Kulzer, Inc. · Jan 1994
STO2P
K934611 · Ivoclar North America, Inc. · Nov 1993
SR SPECTRASIT, SR CHROMASIT
K930128 · Ivoclar North America, Inc. · Oct 1993
VLC DR MATERIAL
K932395 · Dentsply Intl. · Aug 1993
VARIOLINK
K931309 · Ivoclar North America, Inc. · Jul 1993
CHARISMA -- MODIFIED
K932013 · Heraeus Kulzer, Inc. · Jul 1993