FDA.reportPublic FDA data

StecoTitanmagnetics®

Primary DI
ESTOI6501K3000
Brand
StecoTitanmagnetics®
Company
steco-System-Technik GmbH & Co KG
Model
I.65.01.K300
Catalog number
I.65.01.K300
Device description
Titanmagnetics® Insert K-Line D5.2/H3.0 for AstraTech OsseoSpeed TX Implant ø3,5+ø4,0 -> For further information visit steco.de
Published
2025-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGGAttachment, Precision, All

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGGAttachment, Precision, AllDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESTOI6501K3000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic dental precision attachmentA device with magnetic properties designed for fixation of a removable dental prosthesis.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49405577810info@steco.de

Regulatory Flags#

DUNS number
389566209
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H0005KX40StecoTitanmagnetics®H.00.05.KX4H.00.05.KX42026-05-08
H0005TX40StecoTitanmagnetics®H.00.05.TX4H.00.05.TX42026-05-08
ESTOI0107K5000StecoTitanmagnetics®I.01.07.K500I.01.07.K5002025-10-14
ESTOI0206X5200StecoTitanmagnetics®I.02.06.X520I.02.06.X5202025-10-08
ESTOI0207X3700StecoTitanmagnetics®I.02.07.X370I.02.07.X3702025-10-08
ESTOM2701D116L40StecoGuideM.27.01.D116L4M.27.01.D116L42025-10-08
ESTOM2701D205L50StecoGuideM.27.01.D205L5M.27.01.D205L52025-10-08
ESTOM2701D210L50StecoGuideM.27.01.D210L5M.27.01.D210L52025-10-08
ESTOV0003X2600StecoTitanmagnetics®V.00.03.X260V.00.03.X2602025-10-08
ESTOV0008W2650StecoTitanmagnetics®V.00.08.W265V.00.08.W2652025-10-08
ESTOI3401K2500StecoTitanmagnetics®I.34.01.K250I.34.01.K2502025-05-22
ESTOI3401K4500StecoTitanmagnetics®I.34.01.K450I.34.01.K4502025-05-22
ESTOI3401T4000StecoTitanmagnetics®I.34.01.T400I.34.01.T4002025-05-22
ESTOI3401X2600StecoTitanmagnetics®I.34.01.X260I.34.01.X2602025-05-22
ESTOI3401X4500StecoTitanmagnetics®I.34.01.X450I.34.01.X4502025-05-22
ESTOI3401X6000StecoTitanmagnetics®I.34.01.X600I.34.01.X6002025-05-22
ESTOI3401X8000StecoTitanmagnetics®I.34.01.X800I.34.01.X8002025-05-22
ESTOI3401Z4500StecoTitanmagnetics®I.34.01.Z450I.34.01.Z4502025-05-22
ESTOI3402K2000StecoTitanmagnetics®I.34.02.K200I.34.02.K2002025-05-22
ESTOI3402T3000StecoTitanmagnetics®I.34.02.T300I.34.02.T3002025-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H0005KX40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2026-05-08
H0005TX40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2026-05-08
ESTOI0107K5000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-10-14
ESTOV0003X2600StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-10-08
ESTOI6501K4500StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-05-22
00840481134104LOCATOR, compatible with Implant DirectZest Anchors, LLCEGG2023-11-10
18056039211336NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
18056039211503NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
18056039211510NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
18056039211527NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
07640166516125Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
07640173093121Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
07640173093145Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
07640173093268Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
ESTOH0004K20StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004K30StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004K40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004X20StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004Z10StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOU0001Z315K0StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOV0001X2500StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOV0001Z3000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
00810053771891PrimeLocIPBEGG2022-12-15
07630031758743NAInstitut Straumann AGEGG2022-12-02
07630031758750NAInstitut Straumann AGEGG2022-12-02
07630031758767NAInstitut Straumann AGEGG2022-12-02
07630031758774NAInstitut Straumann AGEGG2022-12-02
07630031758781NAInstitut Straumann AGEGG2022-12-02
07630031758798NAInstitut Straumann AGEGG2022-12-02
07630031758804NAInstitut Straumann AGEGG2022-12-02