Cleared Traditional

K001383 - SUPREMCAST V

K001383 is an FDA 510(k) clearance for SUPREMCAST V, manufactured by American Dent-All, Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K001383 · American Dent-All, Inc. · Dental device
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Jul 2000
Decision
64d
Days
Class 2
Risk

K001383 is an FDA 510(k) clearance for the SUPREMCAST V. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by American Dent-All, Inc. (Glendale, US). The FDA issued a Cleared decision on July 5, 2000 after a review of 64 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.

FDA 510(k) Submission Details - K001383

510(k) Number K001383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2000
Decision Date July 05, 2000
Days to Decision 64 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
64d faster than avg
Panel avg: 128d · This submission: 64d
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 151
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K001383.
SUPER 12
K002301 · Dental Alloy Products, Inc. · Sep 2000
SUPER 1
K002298 · Dental Alloy Products, Inc. · Aug 2000
DC TITAN
K001798 · Austenal, Inc. · Jul 2000
DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC
K001269 · Dentalmatic Technologies, Inc. · Jun 2000
CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX
K000981 · C-Mix · Jun 2000
CERADIUM V NON-PRECIOUS CERAMIC ALLOY
K993572 · Matech, Inc. · Dec 1999
K001383 · SUPREMCAST V
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