Cleared Traditional

NPG + 2

K972971 · Aalba Dent, Inc. · Dental
Jan 1998
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K972971 is an FDA 510(k) clearance for the NPG + 2, a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Aalba Dent, Inc. (Fairfield, US). The FDA issued a Cleared decision on January 5, 1998, 147 days after receiving the submission on August 11, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K972971 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1997
Decision Date January 05, 1998
Days to Decision 147 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