NEUN— 510(k) K073554

Substantially Equivalent

Heraeus Kulzer,GmbH

FDA 510(k) clearance K073554 for NEUN, Substantially Equivalent on 2008-02-04. Applicant: Heraeus Kulzer,GmbH. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer,GmbH
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2007-12-18
Decision date: 2008-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Heraeus Kulzer,GmbH

K083652 — IBOND TOTAL ETCH2009-01-21
K080338 — CUTTERSIL ACTIVATOR UNIVERSAL PLUS2008-04-21
K062515 — RETENTION FLOW OPAQUE2006-11-22
K050085 — OSTEOPAL V2005-09-14
K050854 — PALACOS LV+G2005-07-07

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