Cleared Traditional

K854285 - GDC 1453 CASTING ALLOY

K854285 is the FDA 510(k) clearance for GDC 1453 CASTING ALLOY by Deringer-Ney, Inc.. It is a Class 2 Dental device (product code EJH) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K854285 · Deringer-Ney, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
63d
Days
Class 2
Risk

K854285 is an FDA 510(k) clearance for the GDC 1453 CASTING ALLOY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Deringer-Ney, Inc. (Bloomfield, US). The FDA issued a Cleared decision on December 27, 1985 after a review of 63 days - a notably fast clearance 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: 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 K854285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1985
Decision Date December 27, 1985
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K854285.
TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
K896501 · Leach and Dillon Co., Inc. · Feb 1990
RX ASPEN
K882170 · Jeneric/Pentron, Inc. · Jun 1988
PARTIAL DENTURE ALLOY
K860437 · Dentsply Intl. · Mar 1986
BASE METAL ALLOY
K842551 · Dentsply Intl. · Aug 1984
PARTIAL DENTURE ALLOY
K833512 · Dentsply Intl. · Dec 1983
CAVIDRY
K822896 · Parker Laboratories, Inc. · Oct 1982