Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681356

FEI Number

3006349398

Entity Name

KETTENBACH GMBH & CO KG

City/State/Country

ESCHENBURG Hesse, DE

Establishment Address

IM HEERFELD 7, ESCHENBURG Hesse 35713, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KETTENBACH GMBH & CO KG (Owner Number: 9022134)

Owner / Operator Contact Address

IM HEERFELD 7, --, ESCHENBURG, DE-HE 35713, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Visalys CemCore Panasil contact (two in one, Panasil tray (fast, soft) Panasil putty (putty, putty fast set, putty soft), Panasil binetics plus) (putty fast, putty soft), Panasil Monophase Silginat Silginat Strawberry Identium Medium Soft, Identium Light, Identium Medium Identium Heavy Materials Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan) Bite Registration Multi Tray MUCOPREN SOFT RELINING SYSTEM ProphyProtect soft fast 1:1, soft fast 5:1) x-light, X-light fast) Panasil Initial contact (regular, Panasil tray (fast 1:1, regular fast, light, light fast Visalys Temp Visalys BioCeramic Block Mucopren Accessory Panasil Adhesive Identium Adhesive

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMA	Cement, Dental	Dental	Class 2	872.3275	2019-11-13
ELW	Material, Impression	Dental	Class 2	872.3660	2008-10-28
ELW	Material, Impression	Dental	Class 2	872.3660	2008-08-22
ELW	Material, Impression	Dental	Class 2	872.3660	2009-10-19
ELW	Material, Impression	Dental	Class 2	872.3660	2008-05-27
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2010-07-02
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2023-02-20
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-02-20
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2007-08-22
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2026-06-02
ELW	Material, Impression	Dental	Class 2	872.3660	2009-01-14
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2013-01-11
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2015-03-26
ELW	Material, Impression	Dental	Class 2	872.3660	2025-04-25
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2026-01-08
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2006-04-10
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2023-02-20
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-02-20
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2019-11-13
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2009-01-29

Official Correspondent

Katja Simon

US Agent Details

Wilfried Roggenbau Business: InterGest North America LLC Email: w.roggenbau@intergestna.com Phone: (631) 5010500

Related Public Records

Same Entity

KETTENBACH GMBH & CO KG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09
K940030	Bisco, Inc.	BISCO COMPOSITE	1994-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

Similar Registrations

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3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3035693034	Solventum Germany GmbH	Kist Bavaria, DE
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3003775534	GC EUROPE N.V.	LEUVEN Vlaams Brabant, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681356. Last updated year: 2026. Please use registration number 9681356 when referencing this establishment in official correspondence.