Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006098230

FEI Number

3006098230

Entity Name

SICAT GMBH & CO. KG

City/State/Country

BONN North Rhine-Westphalia, DE

Establishment Address

Friesdorfer Strasse 131-135, BONN North Rhine-Westphalia 53175, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SICAT GMBH & CO. KG (Owner Number: 9087842)

Owner / Operator Contact Address

Friesdorfer Strasse 131-135, --, BONN, DE-NW 53175, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180262

PMA Number

N/A

All Registered Proprietary Names

Endo Dental Bur Paraocclusal Attachment Fusion Bite Fusion Bite Adapter SICAT AIR SICAT ACCESSGUIDE SICAT IMPLANT SICAT OPTISLEEP SICAT FUNCTION SICAT ENDO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2018-07-06
NFS	Device, Jaw Tracking, For Monitoring Jaw Positions	Dental	Class 1	872.2060	2013-10-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-12-17
EJL	Bur, Dental	Dental	Class 1	872.3240	2018-05-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-12-06
LQZ	Device, Jaw Repositioning	Dental	Class 2	872.5570	2016-04-04
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2016-04-04
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-03-04
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-03-27

Official Correspondent

Manfred Breuer

US Agent Details

Xenia Mardak Email: Xenia.Mardak@sicat.com Phone: (415) 4208720

Related Public Records

Same Entity

SICAT 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
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

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9611385	Solventum Germany GmbH	SEEFELD Bavaria, DE
3011808221	NOVA IMPLANTS LTD	Or-Yehuda Tel Aviv, IL
3008309654	INNOBIOSURG CO., LTD.	Daejeon, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006098230. Last updated year: 2026. Please use registration number 3006098230 when referencing this establishment in official correspondence.