Kettenbach GmbH & Co. KG - FDA 510(k) Cleared Devices
Recent clearances: Profisil Free, Visalys® Bulk Fill 1 x 4 g Syringe (15060), 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)
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kettenbach GmbH & Co. KG Dental ✕
14 devices
Cleared
Sep 03, 2026
Profisil Free
Dental
64d
Cleared
Mar 14, 2025
Visalys® Bulk Fill 1 x 4 g Syringe (15060)
Dental
43d
Cleared
Jul 24, 2023
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish...
Dental
167d
Cleared
Nov 08, 2019
Visalys CemCore, Visalys Cem Core Try In Paste
Dental
151d
Cleared
Oct 09, 2019
Visalys Restorative Primer
Dental
121d
Cleared
Sep 29, 2019
Visalys Tooth Primer
Dental
111d
Cleared
Mar 25, 2015
Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X
Dental
147d
Cleared
Dec 27, 2012
KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B
Dental
169d
Cleared
Nov 14, 2011
IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM,...
Dental
7d
Cleared
Oct 01, 2009
IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT
Dental
13d
Cleared
Jan 09, 2009
PANASIL INITIAL CONTACT AND PANASIL TRAY
Dental
25d
Cleared
Sep 08, 2008
PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND...
Dental
4d
Cleared
Aug 06, 2008
KETTOSIL AND SILGINAT
Dental
6d
Cleared
May 01, 2008
FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE...
Dental
10d