Cleared Traditional

K935388 - CERAPALL 4CF

K935388 is an FDA 510(k) clearance for CERAPALL 4CF, manufactured by Metalor. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 58-day FDA review.

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

FDA 510(k) Submission Details - K935388

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.

EJS Device Classification - Class 2, Special Controls

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 172
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K935388.
STERNGOLD BIO-4
K962304 · Sterngold/Implamed · Jul 1996
STERNGOLD G-HARD METAL ALLOY
K962301 · The Stern Metals Co., Inc. · Jul 1996
CU-FREE & LTA
K934757 · Jeneric/Pentron, Inc. · Feb 1994
ARGELITE A
K934773 · Argen Precious Metals, Inc. · Dec 1993
VS 1A
K933563 · Metalor Dental USA Corp. · Oct 1993
CORRECT AND CORRECT FIT II
K925331 · Jeneric/Pentron, Inc. · May 1993