Cleared Traditional

VERA PDN

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

About This 510(k) Submission

K972118 is an FDA 510(k) clearance for the VERA PDN, 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 August 15, 1997, 71 days after receiving the submission on June 5, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K972118 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EJH — Alloy, Metal, Base
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3710