Cleared Traditional

K854878 - H40 BASE METAL ALLOY

K854878 is an FDA 510(k) clearance for H40 BASE METAL ALLOY, manufactured by Jeneric Ind.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K854878 · Jeneric Ind. · Dental device
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Jan 1986
Decision
55d
Days
Class 2
Risk

K854878 is an FDA 510(k) clearance for the H40 BASE METAL ALLOY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Jeneric Ind. (Wallingford, US). The FDA issued a Cleared decision on January 30, 1986 after a review of 55 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 Jeneric Ind. devices

FDA 510(k) Submission Details - K854878

510(k) Number K854878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1985
Decision Date January 30, 1986
Days to Decision 55 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
72d faster than avg
Panel avg: 127d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJH Device Classification - Class 2, Special Controls

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 79
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K854878.
BIOSIL H
K861787 · Degussa Dental, Inc. · May 1986
PARTIAL DENTURE ALLOY
K860437 · Dentsply Intl. · Mar 1986
SPARTAN SOLDER
K854738 · Williams Gold Refining Co., Inc. · Mar 1986
GDC 1453 CASTING ALLOY
K854285 · Deringer-Ney, Inc. · Dec 1985
CERAMIC ALLOY NO. DW 179
K852895 · Williams Gold Refining Co., Inc. · Oct 1985
VERA BOND NON PERCIOUS CERAMIC ALLOY
K851569 · Aalba Dent, Inc. · May 1985