Cleared Traditional

VERA PDS & VERA PDI

K915249 · Aalba Dent, Inc. · Dental

Mar 1992

Decision

108d

Days

Class 2

Risk

About This 510(k) Submission

K915249 is an FDA 510(k) clearance for the VERA PDS & VERA PDI, a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Aalba Dent, Inc. (Chicago, US). The FDA issued a Cleared decision on March 2, 1992, 108 days after receiving the submission on November 15, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number	K915249 FDA.gov
FDA Decision	Cleared 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