Data / Medical devices / Germany / Sicat GMBH & Co. KG

Sicat GMBH & Co. KG: FDA-registered device maker in BONN North Rhine-Westphalia, Germany, 5 510(k) clearances

Name: Sicat GMBH & Co. KG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sicat GMBH & Co. KG is registered with the FDA (registration 3006098230) in BONN North Rhine-Westphalia, Germany. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 4, 2019. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006098230
Address: Friesdorfer Strasse, BONN North Rhine-Westphalia, Germany, 53175
Owner or operator: SICAT GMBH & CO. KG (9087842)
Roles: Exporter to the US, Manufacturer
First device listed: May 18, 2007
Registered through: 2026
Brand names listed: Endo Dental Bur, Fusion Bite, Fusion Bite Adapter, Paraocclusal Attachment, SICAT ACCESSGUIDE, SICAT AIR, SICAT BITE PLATE, SICAT ENDO and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Manufacturer	accessdata.fda.gov
Device, Anti-Snoring	LRK	2	Manufacturer	accessdata.fda.gov
Device, Jaw Repositioning	LQZ	2	Manufacturer	accessdata.fda.gov
Device, Jaw Tracking, For Monitoring Jaw Positions	NFS	1	Exporter to the US	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Exporter to the US	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 4, 2019	K192348	SICAT Implant V2.0	LLZ	Substantially Equivalent	Sicat GmbH & Co. KG	accessdata.fda.gov
March 12, 2018	K180262	SICAT Endo	LLZ	Substantially Equivalent	Sicat GmbH & Co. KG	accessdata.fda.gov
March 31, 2016	K153291	SICAT OPTISLEEP	LRK	Substantially Equivalent	Sicat GmbH & Co. KG	accessdata.fda.gov
November 16, 2015	K152661	HICAT Air	LLZ	Substantially Equivalent	Hicat GmbH	accessdata.fda.gov
February 25, 2014	K133320	SICAT FUNCTION	LLZ	Substantially Equivalent	Sicat GmbH & Co. KG	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 15, 2020	86165	Class II	Terminated	SICAT IMPLANT V2.0	A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD.	accessdata.fda.gov

Compare with other makers

Updated December 4, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.