Cleared Traditional

K820328 - NICKEL-BASED DENTAL CASTING ALLOY

K820328 is the FDA 510(k) clearance for NICKEL-BASED DENTAL CASTING ALLOY by Dentsply Intl.. It is a Class 2 Dental device (product code EJH) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K820328 · Dentsply Intl. · Dental device

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Mar 1982

Decision

22d

Days

Class 2

Risk

K820328 is an FDA 510(k) clearance for the NICKEL-BASED DENTAL CASTING ALLOY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1982 after a review of 22 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 Dentsply Intl. devices

Submission Details

510(k) Number	K820328 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 08, 1982
Decision Date	March 02, 1982
Days to Decision	22 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

105d faster than avg

Panel avg: 127d · This submission: 22d

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 K820328.

BASE METAL ALLOY

K842551 · Dentsply Intl. · Aug 1984

PARTIAL DENTURE ALLOY

K833512 · Dentsply Intl. · Dec 1983

CAVIDRY

K822896 · Parker Laboratories, Inc. · Oct 1982

BASE METAL ALLOY

K811258 · Dentsply Intl. · Jul 1981

SUMMAR NON-PRECIOUS, CERAMIC ALLOY

K811013 · Shofu Dental Corp. · Jun 1981

BA-93

K811407 · Deringer-Ney, Inc. · Jun 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K820328

Dentsply Intl.

Mchenry, IL · US

Regulatory profile

279 submissions 279 cleared

100% clearance rate · Active in Dental

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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