Cleared Traditional

PROMETAL HN86

K052463 · Prometal Technologies · Dental

Oct 2005

Decision

36d

Days

Class 2

Risk

About This 510(k) Submission

K052463 is an FDA 510(k) clearance for the PROMETAL HN86, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Prometal Technologies (Silver Creek, US). The FDA issued a Cleared decision on October 14, 2005, 36 days after receiving the submission on September 8, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number	K052463 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 2005
Decision Date	October 14, 2005
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement