HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM— 510(k) K034049

Name: FDA 510(k) clearance K034049
Creator: U.S. Food and Drug Administration
Published: 2004-03-01

Substantially Equivalent

Heraeus Kulzer,GmbH

FDA 510(k) clearance K034049 for HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM, Substantially Equivalent on 2004-03-01. Applicant: Heraeus Kulzer,GmbH. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer,GmbH
Product code: Code EJT
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 2003-12-30
Decision date: 2004-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJT

view all

More clearances from Heraeus Kulzer,GmbH

view all

K083652 — IBOND TOTAL ETCH2009-01-21
K080338 — CUTTERSIL ACTIVATOR UNIVERSAL PLUS2008-04-21
K073554 — NEUN2008-02-04
K062515 — RETENTION FLOW OPAQUE2006-11-22
K050085 — OSTEOPAL V2005-09-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.