Cleared Traditional

FUTURA TOPCAP NON GAMMA-2

K011801 · Ab Ardent · Dental

Aug 2001

Decision

69d

Days

Class 2

Risk

About This 510(k) Submission

K011801 is an FDA 510(k) clearance for the FUTURA TOPCAP NON GAMMA-2, a Alloy, Amalgam (Class II — Special Controls, product code EJJ), submitted by Ab Ardent (Tonawanda, US). The FDA issued a Cleared decision on August 16, 2001, 69 days after receiving the submission on June 8, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3070.

Submission Details

510(k) Number	K011801 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 2001
Decision Date	August 16, 2001
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement