Cleared Traditional

K002298 - SUPER 1

K002298 is an FDA 510(k) clearance for SUPER 1, manufactured by Dental Alloy Products, Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K002298 · Dental Alloy Products, Inc. · Dental device
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Aug 2000
Decision
27d
Days
Class 2
Risk

K002298 is an FDA 510(k) clearance for the SUPER 1. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Dental Alloy Products, Inc. (Compton, US). The FDA issued a Cleared decision on August 24, 2000 after a review of 27 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 Dental Alloy Products, Inc. devices

FDA 510(k) Submission Details - K002298

510(k) Number K002298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2000
Decision Date August 24, 2000
Days to Decision 27 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 127d · This submission: 27d
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 100
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K002298.
AUROFILM NP
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GOLD CORE II
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CERADIUM V NON-PRECIOUS CERAMIC ALLOY
K993572 · Matech, Inc. · Dec 1999
HI BOND NON-PRECIOUS CERAMIC ALLOY
K992881 · Matech, Inc. · Nov 1999
P10 SPECIAL
K993344 · North American Alloys, Inc. · Nov 1999