Cleared Traditional

K973569 - SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY

K973569 is an FDA 510(k) clearance for SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY, manufactured by C.K. International Trading. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K973569 · C.K. International Trading · Dental device
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Dec 1997
Decision
83d
Days
Class 2
Risk

K973569 is an FDA 510(k) clearance for the SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by C.K. International Trading (Arcadia, US). The FDA issued a Cleared decision on December 11, 1997 after a review of 83 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 C.K. International Trading devices

FDA 510(k) Submission Details - K973569

510(k) Number K973569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1997
Decision Date December 11, 1997
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 127d · This submission: 83d
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 97
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K973569.
NPG + 2
K972971 · Aalba Dent, Inc. · Jan 1998
SOWELL COBALT-CHROME METAL ALLOY
K973567 · C.K. International Trading · Dec 1997
SOWELL NICKEL-CHROME NON-PRECIOUS METAL ALLOY
K973568 · C.K. International Trading · Dec 1997
SOWELL PATENTED NON-PRECIOUS METAL ALLOY
K973566 · C.K. International Trading · Dec 1997
VERABOND 2V
K973265 · Aalba Dent, Inc. · Oct 1997
PLATALLOY
K972607 · Aalba Dent, Inc. · Oct 1997