Cleared Traditional

K911323 - FLUX-N-ALL

K911323 is an FDA 510(k) clearance for FLUX-N-ALL, manufactured by Precident Corp.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K911323 · Precident Corp. · Dental device
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Sep 1991
Decision
189d
Days
Class 2
Risk

K911323 is an FDA 510(k) clearance for the FLUX-N-ALL. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Precident Corp. (Glenview, US). The FDA issued a Cleared decision on September 30, 1991 after a review of 189 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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 Precident Corp. devices

FDA 510(k) Submission Details - K911323

510(k) Number K911323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1991
Decision Date September 30, 1991
Days to Decision 189 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 127d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJH Device Classification - Class 2, Special Controls

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 100
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K911323.
NPG III CASTING ALLOY
K915247 · Aalba Dent, Inc. · Dec 1991
LPG CASTING ALLOY
K915248 · Aalba Dent, Inc. · Dec 1991
ROCATEC(R) -PLUS
K913857 · Espe GmbH (Us) · Dec 1991
(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE
K901552 · Nobelpharma USA, Inc. · Jun 1991
WIRON 99 DENTAL CASTING ALLOY
K903538 · Leach and Dillon Co., Inc. · Mar 1991
VIDENT 90 ALLOY AND VIDENT 95 ALLOY
K903008 · Vident · Sep 1990