FDA.reportPublic FDA data

StecoGuide

Primary DI
ESTOM2733D390L50
Brand
StecoGuide
Company
steco-System-Technik GmbH & Co KG
Model
M.27.33.D390L5
Catalog number
M.27.33.D390L5
Device description
Titanium guide sleeve compatible to Straumann iGuide™ Ø3,9 D5.2/d3.9/L5.0 -> For further information visit steco.de
Published
2026-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
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
M2733D390L52PackageHIBCC5In Commercial Distribution
ESTOM2733D390L50PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06009544030287N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052401N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052418N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052425N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052432N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052517N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052524N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052531N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052548N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052555N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052630N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052647N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052654N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052661N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052678N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052685N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052692N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052708N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052715N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052722N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052739N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052746N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052753N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052760N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052777N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053224N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053255N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053262N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053279N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053286N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01