Cleared Traditional

CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL RESTOR. (K892907) - FDA 510(k) Clearance

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

K892907 · Deringer-Ney, Inc. · Dental device
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Jun 1989
Decision
47d
Days
Class 2
Risk

K892907 is an FDA 510(k) clearance for the CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL RESTOR.. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Deringer-Ney, Inc. (Bloomfield, US). The FDA issued a Cleared decision on June 6, 1989 after a review of 47 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 Deringer-Ney, Inc. devices

Submission Details

510(k) Number K892907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1989
Decision Date June 06, 1989
Days to Decision 47 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 127d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJT Alloy, Gold-based 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 - EJT Alloy, Gold-based Noble Metal

All 208
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K892907.
ARGELITE 54B
K892811 · Argen Precious Metals, Inc. · Jun 1989
ARGENCO W+
K893227 · Argen Precious Metals, Inc. · Jun 1989
ARGENCO W
K893237 · Argen Precious Metals, Inc. · Jun 1989
ARGELITE 54+
K893010 · Argen Precious Metals, Inc. · Jun 1989
ARGENCO W-LITE
K893228 · Argen Precious Metals, Inc. · Jun 1989
ARGENCO WLF
K893238 · Argen Precious Metals, Inc. · Jun 1989