Cleared Traditional

K850101 - GDC-1629 A CASTING ALLOY

K850101 is the FDA 510(k) clearance for GDC-1629 A CASTING ALLOY by Deringer-Ney, Inc.. It is a Class 2 Dental device (product code EJS) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K850101 · Deringer-Ney, Inc. · Dental device
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Feb 1985
Decision
28d
Days
Class 2
Risk

K850101 is an FDA 510(k) clearance for the GDC-1629 A CASTING ALLOY. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Deringer-Ney, Inc. (Bloomfield, US). The FDA issued a Cleared decision on February 8, 1985 after a review of 28 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 K850101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1985
Decision Date February 08, 1985
Days to Decision 28 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
99d faster than avg
Panel avg: 127d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 117
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K850101.
GDC 1830 CASTING ALLOY
K871288 · Deringer-Ney, Inc. · Apr 1987
GDC 1742 (A CASTING ALLOY FOR DENTAL RESTORATIONS)
K860119 · Deringer-Ney, Inc. · Mar 1986
DENTAL CASTING ALLOY GDC 1686
K852347 · Deringer-Ney, Inc. · Jul 1985
GDC-1433 A CASTING ALLOY
K850102 · Deringer-Ney, Inc. · Feb 1985
GDC-1489 A CASTING ALLOY
K850103 · Deringer-Ney, Inc. · Feb 1985
CERAMCO * HIGH FUSING FOIL SOLDER
K833434 · Johnson & Johnson Professionals, Inc. · Dec 1983