Cleared Traditional

K924292 - CERAPALL 6 -- MODIFIED

K924292 is an FDA 510(k) clearance for CERAPALL 6 -- MODIFIED, manufactured by Metalor Dental USA Corp.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K924292 · Metalor Dental USA Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
245d
Days
Class 2
Risk

K924292 is an FDA 510(k) clearance for the CERAPALL 6 -- MODIFIED. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on March 1, 1993 after a review of 245 days - an extended review 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: 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 Metalor Dental USA Corp. devices

FDA 510(k) Submission Details - K924292

510(k) Number K924292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1992
Decision Date March 01, 1993
Days to Decision 245 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 127d · This submission: 245d
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 171
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K924292.
BIO C & B
K926146 · Jeneric/Pentron, Inc. · May 1993
GOLD-PLATINUM BASED CASTING ALLOY
K926147 · Jeneric/Pentron, Inc. · May 1993
NUGOLD 2%
K926145 · Jeneric/Pentron, Inc. · May 1993
KB58-KF
K922958 · Jeneric/Pentron, Inc. · Feb 1993
ZENON PLUS
K922955 · Jeneric/Pentron, Inc. · Dec 1992
GDC 3445
K925273 · Deringer-Ney, Inc. · Dec 1992