Cleared Traditional

K801009 - HOWMEDICA WHITE C&B ALLOY

K801009 is an FDA 510(k) clearance for HOWMEDICA WHITE C&B ALLOY, manufactured by Dental Laboratory Products Div.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K801009 · Dental Laboratory Products Div. · Dental device
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Jun 1980
Decision
37d
Days
Class 2
Risk

K801009 is an FDA 510(k) clearance for the HOWMEDICA WHITE C&B ALLOY. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Dental Laboratory Products Div. (Mchenry, US). The FDA issued a Cleared decision on June 4, 1980 after a review of 37 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 Dental Laboratory Products Div. devices

FDA 510(k) Submission Details - K801009

510(k) Number K801009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1980
Decision Date June 04, 1980
Days to Decision 37 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 128d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJS Device Classification - Class 2, Special Controls

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 172
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K801009.
PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS
K811563 · Williams Gold Refining Co., Inc. · Jul 1981
HOWMEDICA T-III G ALLOY
K810380 · Howmedica Corp. · Mar 1981
GDC 934
K801277 · Deringer-Ney, Inc. · Jul 1980
AUSTRY ALLOY(DENTAL BAKE-ON ALLOY)
K800994 · Howmedica Corp. · May 1980
TEMPO
K792274 · Deringer-Ney, Inc. · Nov 1979
HOWMEDICA A-35 DENTAL ALLOY
K791973 · Howmedica Corp. · Nov 1979