Cleared Traditional

K040180 - CONTINUM V

K040180 is an FDA 510(k) clearance for CONTINUM V, manufactured by Aalba Dent, Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K040180 · Aalba Dent, Inc. · Dental device
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Mar 2004
Decision
37d
Days
Class 2
Risk

K040180 is an FDA 510(k) clearance for the CONTINUM V. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Aalba Dent, Inc. (Fairfield, US). The FDA issued a Cleared decision on March 4, 2004 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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 Aalba Dent, Inc. devices

FDA 510(k) Submission Details - K040180

510(k) Number K040180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2004
Decision Date March 04, 2004
Days to Decision 37 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
90d faster than avg
Panel avg: 127d · This submission: 37d
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 99
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K040180.
BEGOPAL+
K123929 · Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO · Mar 2013
CONTINUM
K040179 · Aalba Dent, Inc. · Mar 2004
VERASOFT ES
K033356 · Aalba Dent, Inc. · Dec 2003
KAVO EVEREST TITANBLANK
K024214 · Kavo America · Mar 2003
4 ALL (DW286A)
K020253 · Ivoclar Vivadent, Inc. · Apr 2002
D.SIGN 15 (DW286 B)
K020898 · Ivoclar Vivadent, Inc. · Mar 2002