IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT— 510(k) K113279

Name: FDA 510(k) clearance K113279
Creator: U.S. Food and Drug Administration
Published: 2011-11-14

Substantially Equivalent

Kettenbach GmbH & Co. KG

FDA 510(k) clearance K113279 for IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT, Substantially Equivalent on 2011-11-14. Applicant: Kettenbach GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Kettenbach GmbH & Co. KG
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2011-11-07
Decision date: 2011-11-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Eschenburg, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELW

view all

K254112 — Dia-X Sil Bite2026-03-19
K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037) +9 more2025-10-31
K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST2025-06-27
K241924 — Elastic Impression Material2024-12-27
K242360 — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator2024-11-15

More clearances from Kettenbach GmbH & Co. KG

view all

K262243 — Profisil Free2026-09-03
K250267 — Visalys® Bulk Fill 1 x 4 g Syringe (15060) +5 more2025-03-14
K230333 — Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)2023-07-24
K191527 — Visalys CemCore, Visalys Cem Core Try In Paste2019-11-08
K191523 — Visalys Restorative Primer2019-10-09

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