# Kettenbach GmbH & Co. KG

- Location (FDA's records): Eschenburg, DE
- FDA decisions: 14 (2008–2026): 14 510(k) clearances
- Product codes: ELW (6), EBF (2), LBH (2), KLE (2), EBG (1), EMA (1)
- 510(k) review time since 2016: median 116 days, against 135 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 33 (7 its own); citations of its devices by later devices: 10 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dentsply Intl.: 3 (https://510kreport.com/company/dentsply-intl)
- Dmg USA, Inc.: 2 (https://510kreport.com/company/dmg-usa)
- Ivoclar Vivadent, Inc.: 2 (https://510kreport.com/company/ivoclar-vivadent)
- Roydent Dental Products, Inc.: 2 (https://510kreport.com/company/roydent-dental-products)
- Kuraray Noritake Dental, Inc.: 2 (https://510kreport.com/company/kuraray-noritake-dental)
- Sybron Dental Specialties, Inc.: 2 (https://510kreport.com/company/sybron-dental-specialties)
- GC America, Inc.: 2 (https://510kreport.com/company/gc-america)
- Voco GmbH: 1 (https://510kreport.com/company/voco)

## Firms that cite its devices most
- Dreve Dentamid GmbH: 1 (https://510kreport.com/company/dreve-dentamid)
- Osstem Germany GmbH: 1 (https://510kreport.com/company/osstem-germany)
- Vericom Co., Ltd.: 1 (https://510kreport.com/company/vericom)

## Its most-cited devices
- K082560: Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and Contact (2008), cited by 5
- K081120: Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite Registration Materials (2008), cited by 2
- K143104: Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X (2015), cited by 1
- K083701: Panasil Initial Contact and Panasil Tray (2009), cited by 1
- K092867: Identium Heavy, Medium, Medium Soft, Light (2009), cited by 1

## Recent decisions
- K262243: Profisil Free (Sep 3, 2026)
- K250267: Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) (Mar 14, 2025)
- 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) (Jul 24, 2023)
- K191527: Visalys CemCore, Visalys Cem Core Try In Paste (Nov 8, 2019)
- K191523: Visalys Restorative Primer (Oct 9, 2019)
- K191524: Visalys Tooth Primer (Sep 29, 2019)
- K143104: Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X (Mar 25, 2015)
- K122039: Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross B (Dec 27, 2012)

Source page: https://510kreport.com/company/kettenbach