Cleared Traditional

K860217 - NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY)

K860217 is an FDA 510(k) clearance for NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY), manufactured by Austenal Dental, Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K860217 · Austenal Dental, Inc. · Dental device
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Mar 1986
Decision
54d
Days
Class 2
Risk

K860217 is an FDA 510(k) clearance for the NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY). Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Austenal Dental, Inc. (Chicago, US). The FDA issued a Cleared decision on March 17, 1986 after a review of 54 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 Austenal Dental, Inc. devices

FDA 510(k) Submission Details - K860217

510(k) Number K860217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1986
Decision Date March 17, 1986
Days to Decision 54 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
73d faster than avg
Panel avg: 127d · This submission: 54d
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 86
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K860217.
NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY
K862417 · Austenal Dental, Inc. · Jul 1986
BIOSIL F
K861820 · Degussa Dental, Inc. · Jun 1986
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
H40 BASE METAL ALLOY
K854878 · Jeneric Ind. · Jan 1986