Cleared Traditional

HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM

K034049 · Heraeus Kulzer,GmbH · Dental

Mar 2004

Decision

62d

Days

Class 2

Risk

About This 510(k) Submission

K034049 is an FDA 510(k) clearance for the HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Heraeus Kulzer,GmbH (South Bend, US). The FDA issued a Cleared decision on March 1, 2004, 62 days after receiving the submission on December 30, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number	K034049 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 30, 2003
Decision Date	March 01, 2004
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement