Cleared Traditional

K033356 - VERASOFT ES

K033356 is the FDA 510(k) clearance for VERASOFT ES by Aalba Dent, Inc.. It is a Class 2 Dental device (product code EJH) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K033356 · Aalba Dent, Inc. · Dental device
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Dec 2003
Decision
101d
Days
Class 2
Risk

K033356 is an FDA 510(k) clearance for the VERASOFT ES. 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 December 30, 2003 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Aalba Dent, Inc. devices

Submission Details

510(k) Number K033356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2003
Decision Date December 30, 2003
Days to Decision 101 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
26d faster than avg
Panel avg: 127d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K033356.
4 ALL (DW286A)
K020253 · Ivoclar Vivadent, Inc. · Apr 2002
D.SIGN 15 (DW286 B)
K020898 · Ivoclar Vivadent, Inc. · Mar 2002
PISCES PLUS (DW286 C)
K020183 · Ivoclar Vivadent, Inc. · Mar 2002
D.SIGN 30
K010381 · Ivoclar North America, Inc. · Mar 2001
AUROFILM NP
K003387 · Metalor Dental USA Corp. · Jan 2001
JEWEL CAST III
K003037 · Jeneric/Pentron, Inc. · Dec 2000