SYCOTEC GMBH & CO KG

FDA Device Registration & Listing · Leutkirch Baden-Wurttemberg, DE · Registration 3009302876

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009302876
FEI Number
3009302876
Entity Name
SYCOTEC GMBH & CO KG
City/State/Country
Leutkirch Baden-Wurttemberg, DE
Establishment Address
Wangener Strasse 78, Leutkirch Baden-Wurttemberg 88299, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
SYCOTEC GMBH & CO KG (Owner Number: 10047093)
Owner / Operator Contact Address
Wangener Strasse 78, Leutkirch, DE-BW 88299, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K132356
PMA Number
N/A

All Registered Proprietary Names

E-SANAO Advantage E-STATIS Advantage A-dec XC10 Electric Motor Midwest E Electric Handpiece System E-SANAO Prep Star ETorque Electric Motor System E-STATIS Prep NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM STATMATIC 31 Midwest Plus Automate Spray Midwest® 6-pin Coupler, K-style CE STATIS, ML and SL SANAO 10L/10 SANAO 40ST ETorque Handpieces SANAO 200L SANAO 40L/40 SANAO PSI/PSO Midwest E Attachments STERLING

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2014-06-27
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2017-11-14
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2014-12-18
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2019-08-22
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2014-12-18
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2014-06-30

Official Correspondent

Ralph Hoffmann

US Agent Details

Eric Ozelski Business: OzGlobal LLC Email: Eric_ozelski@hotmail.com Phone: (412) 4209985

Related Public Records

Same Entity

SYCOTEC 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
K040153 Indigenous Peoples Technology and Education Center I-TEC PORTABLE DENTAL OPERATORY 2004-05-21
K212910 Shenzhen Carejoy Technology Co., Ltd. Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece 2022-11-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009302876. Last updated year: 2026. Please use registration number 3009302876 when referencing this establishment in official correspondence.
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