Cleared Traditional

CERAPALL 4CF (K935388) - FDA 510(k) Clearance

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

K935388 · Metalor · Dental device
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Jan 1994
Decision
58d
Days
Class 2
Risk

K935388 is an FDA 510(k) clearance for the CERAPALL 4CF. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Metalor (Rockville Centre, US). The FDA issued a Cleared decision on January 6, 1994 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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 Metalor devices

Submission Details

510(k) Number K935388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1993
Decision Date January 06, 1994
Days to Decision 58 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
69d faster than avg
Panel avg: 127d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJS Alloy, Other Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJS Alloy, Other Noble Metal

All 24
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K935388.
ARGELITE A
K934773 · Argen Precious Metals, Inc. · Dec 1993
ARGEBOND 77+
K915165 · Argen Precious Metals, Inc. · Apr 1992
ARGEBOND 80
K913704 · Argen Precious Metals, Inc. · Nov 1991
ULTRACROWN(TM) PD ALLOY POST-SOLDER
K913860 · Dentsply Intl. · Nov 1991
ULTRACROWN(TM) PD DENTAL ALLOY
K913232 · Dentsply Intl. · Sep 1991
MAXIBOND
K911757 · Argen Precious Metals, Inc. · Jun 1991