FDA.reportPublic FDA data

StecoGuide

Primary DI
ESTOM2701D116L40
Brand
StecoGuide
Company
steco-System-Technik GmbH & Co KG
Model
M.27.01.D116L4
Catalog number
M.27.01.D116L4
Device description
Titanium single sleeve D3.0/d1.16/L4.0 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
M2701D116L42PackageHIBCC10In Commercial Distribution
ESTOM2701D116L40PrimaryHIBCC0

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
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
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
ESTOI3402X2600StecoTitanmagnetics®I.34.02.X260I.34.02.X2602025-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14