FDA.reportPublic FDA data

StecoGuide

Primary DI
ESTOM2701D210L50
Brand
StecoGuide
Company
steco-System-Technik GmbH & Co KG
Model
M.27.01.D210L5
Catalog number
M.27.01.D210L5
Device description
Titanium single sleeve D3.0/d2.11/L5.0 for SICAT -> For further information visit steco.de
Published
2025-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M2701D210L52PackageHIBCC10In Commercial Distribution
ESTOM2701D210L50PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, single-useA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
389566209
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ESTOI0207Z4300StecoTitanmagnetics®I.02.07.Z430I.02.07.Z4302026-09-28
ESTOM2733D390L50StecoGuideM.27.33.D390L5M.27.33.D390L52026-09-28
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809918259720LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
03700977513110SlimEUROTEKNIKANDP2026-10-12
03700977513363iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513370iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513387iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513394iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513400iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513417iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513424iFlag ReversoEUROTEKNIKANDP2026-10-12
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03700977513448iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513455iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513462iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513639iFlag ReversoEUROTEKNIKANDP2026-10-12
07290116661322Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-10-11
00810157315762MUA PEEK Comfort CapParagon Implant Mfg., LLCNDP2026-10-09
06942799001100SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-10-09
07899878068143NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068150NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068167NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068174NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
06009544052876N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052883N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052890N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052906N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052920N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052937N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07