Cleared Traditional

K972118 - VERA PDN

K972118 is the FDA 510(k) clearance for VERA PDN by Aalba Dent, Inc.. It is a Class 2 Dental device (product code EJH) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K972118 · Aalba Dent, Inc. · Dental device
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Aug 1997
Decision
71d
Days
Class 2
Risk

K972118 is an FDA 510(k) clearance for the VERA PDN. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Aalba Dent, Inc. (Chicago, US). The FDA issued a Cleared decision on August 15, 1997 after a review of 71 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

Submission Details

510(k) Number K972118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1997
Decision Date August 15, 1997
Days to Decision 71 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
56d faster than avg
Panel avg: 127d · This submission: 71d
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 K972118.
GOLD CORE II
K003039 · Jeneric/Pentron, Inc. · Dec 2000
D-SIGN V (R&D PROJECT DW267#17)
K990182 · Ivoclar North America, Inc. · Mar 1999
D-SIGN VI (R&D PROJECT DW266#9)
K990235 · Ivoclar North America, Inc. · Mar 1999
RX 96E
K963891 · Jeneric/Pentron, Inc. · Nov 1996
SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)
K950894 · Argen Precious Metals, Inc. · Mar 1995
VIDENT 500 ALLOY AND VIDENT 550 BE ALLOY
K932893 · Vident · Mar 1994