Cleared Traditional

K945713 - VERABOND II

K945713 is an FDA 510(k) clearance for VERABOND II, 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 38-day FDA review.

K945713 · Aalba Dent, Inc. · Dental device
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Dec 1994
Decision
38d
Days
Class 2
Risk

K945713 is an FDA 510(k) clearance for the VERABOND II. 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 29, 1994 after a review of 38 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 - K945713

510(k) Number K945713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1994
Decision Date December 29, 1994
Days to Decision 38 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
89d faster than avg
Panel avg: 127d · This submission: 38d
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 K945713.
REMANIUM: 200,CS, 380, AND CD
K952865 · Dentauraum, Inc. · Jul 1995
SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)
K950894 · Argen Precious Metals, Inc. · Mar 1995
VERABOND V
K945712 · Aalba Dent, Inc. · Dec 1994
VERABOND III
K945714 · Aalba Dent, Inc. · Dec 1994
VIDENT 500 ALLOY AND VIDENT 550 BE ALLOY
K932893 · Vident · Mar 1994
LPG 5/10, LPG 10/5, LPG 10/15 AND LPG 15/10
K940749 · Aalba Dent, Inc. · Mar 1994