Cleared Traditional

K972534 - ALFALLOY
(FDA 510(k) Clearance)

K972534 · Aalba Dent, Inc. · Dental

Sep 1997

Decision

60d

Days

Class 2

Risk

K972534 is an FDA 510(k) clearance for the ALFALLOY. This device is classified as a Alloy, Other Noble Metal (Class II — Special Controls, product code EJS).

Submitted by Aalba Dent, Inc. (Fairfield, US). The FDA issued a Cleared decision on September 5, 1997, 60 days after receiving the submission on July 7, 1997.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number	K972534 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 1997
Decision Date	September 05, 1997
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement