Sicat GmbH & Co. KG
BONN North Rhine-Westphalia, DE
SICAT GMBH & CO. KG appears in FDA device records in BONN North Rhine-Westphalia, DE. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Sicat GmbH & Co. KG between 2006 and 2019. The busiest year on record is 2009, with 2. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2009 | 2 |
| 2011 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K192348 | SICAT Implant V2.0 | LLZ | Substantially Equivalent | |
| K180262 | SICAT Endo | LLZ | Substantially Equivalent | |
| K153291 | SICAT OPTISLEEP | LRK | Substantially Equivalent | |
| K143655 | SICAT OPTIMOTION | MQC | Substantially Equivalent | |
| K133320 | SICAT FUNCTION | LLZ | Substantially Equivalent | |
| K103723 | SICAT IMPLANT V1.2 | LLZ | Substantially Equivalent | |
| K093090 | GALILEOS IMPLANT, VERSION 1.7 | LLZ | Substantially Equivalent | |
| K090119 | SICAT IMPLANT | LLZ | Substantially Equivalent | |
| K061472 | GALILEOS IMPLANT, V 1.0 | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006098230 | 3006098230 | SICAT GMBH & CO. KG | Friesdorfer Strasse 131-135, BONN North Rhine-Westphalia 53175 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2951-2020 | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain