FDA Registration Active 🇩🇪 Germany

SYCOTEC GMBH & CO KG

Reg #: 3009302876 · FEI: 3009302876 · Expires 2026
Products
3
Proprietary Names
20
Establishment Types
3
Classifications
3

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Registration Details

Registration Name
SYCOTEC GMBH & CO KG
Registration Number
3009302876
FEI Number
3009302876
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Wangener Strasse 78
City
Leutkirch Baden-Wurttemberg
Country
DE

Regulatory Submissions

510(k) Number
K090937

Owner / Operator

Firm Name
SYCOTEC GMBH & CO KG
Operator Number
10047093
Address
Wangener Strasse 78
City
Leutkirch
State
Baden-Wurttemberg
Postal Code
88299
Country
DE
Correspondent
Ralph Hoffmann

US Agent

Business Name
OzGlobal LLC
Contact Name
Eric Ozelski
Address
2631 Fountain Hills Drive
City
Wexford
State
PA
ZIP
15090
Country
US
Phone
412 4209985

Products

Device Name Product Code
Controller, Foot, Handpiece And Cord EBW
Handpiece, Air-Powered, Dental EFB
Handpiece, Contra- And Right-Angle Attachment, Dental EGS

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

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility