Cleared Traditional

VERA PDS & VERA PDI (K915249) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 10
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K915249.
ARGELOY PARTIAL (NON-PRECIOUS)
K935829 · Argen Precious Metals, Inc. · Jan 1994
ARGELOY N.P. (V) (NON-PRECIOUS DENTAL ALLOY FOR PROCELAIN APPLICATION)
K935972 · Argen Precious Metals, Inc. · Jan 1994
ARGELITE 81SF+
K934768 · Argen Precious Metals, Inc. · Dec 1993
PARTIAL DENTURE ALLOY
K860437 · Dentsply Intl. · Mar 1986
BASE METAL ALLOY
K842551 · Dentsply Intl. · Aug 1984
PARTIAL DENTURE ALLOY
K833512 · Dentsply Intl. · Dec 1983