Cleared Traditional

K915249 - VERA PDS & VERA PDI

K915249 is an FDA 510(k) clearance for VERA PDS & VERA PDI, 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 108-day FDA review.

K915249 · Aalba Dent, Inc. · Dental device
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Mar 1992
Decision
108d
Days
Class 2
Risk

K915249 is an FDA 510(k) clearance for the VERA PDS & VERA PDI. 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 March 2, 1992 after a review of 108 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

FDA 510(k) Submission Details - K915249

510(k) Number K915249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1991
Decision Date March 02, 1992
Days to Decision 108 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
19d faster than avg
Panel avg: 127d · This submission: 108d
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 K915249.
DUCERANIUM U
K926347 · Degussa AG · May 1993
VERASOFT CASTING ALLOY
K925579 · Aalba Dent, Inc. · Mar 1993
DEGUCAST 40
K922790 · Degussa AG · Dec 1992
DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.
K920561 · Ivoclar North America, Inc. · Mar 1992
NPG III CASTING ALLOY
K915247 · Aalba Dent, Inc. · Dec 1991
LPG CASTING ALLOY
K915248 · Aalba Dent, Inc. · Dec 1991