Cleared Traditional

SEQUEL (CASTING ALLOY FOR PORCELAIN-FUSED-METAL) (K893800) - FDA 510(k) Clearance

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

K893800 · Deringer-Ney, Inc. · Dental device
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Dec 1989
Decision
212d
Days
Class 2
Risk

K893800 is an FDA 510(k) clearance for the SEQUEL (CASTING ALLOY FOR PORCELAIN-FUSED-METAL). 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 December 20, 1989 after a review of 212 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 Deringer-Ney, Inc. devices

Submission Details

510(k) Number K893800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1989
Decision Date December 20, 1989
Days to Decision 212 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 127d · This submission: 212d
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 K893800.
ARGENCO 28
K903278 · Argen Precious Metals, Inc. · Aug 1990
ARGENCO 27
K903280 · Argen Precious Metals, Inc. · Aug 1990
ARGELITE 80 + 5 DENTAL ALLOY FOR PORCELAIN APPL.
K896348 · Argen Precious Metals, Inc. · Feb 1990
ARGENCO 50 TYPE IV TYPE IV DENTAL GOLD ALLOY
K893566 · Argen Precious Metals, Inc. · Jul 1989
ARGENCO 68 TYPE IV DENTAL GOLD ALLOY
K893565 · Argen Precious Metals, Inc. · Jun 1989
ARGENCO 56 TYPE IV DENTAL GOLD ALLOY
K893568 · Argen Precious Metals, Inc. · Jun 1989